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Trial record 6 of 166 for:    "Sweat Gland Disease"

GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT01128738
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : April 25, 2012
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hyperhidrosis
Interventions Drug: GSK1358820
Drug: Placebo
Enrollment 152
Recruitment Details  
Pre-assignment Details This study consisted of a Screening Phase (1- to 2-week period), the First Treatment Phase (16- to 40-week period after first treatment), and the open-label Second Treatment Phase (16- to 24-week period after reinjection). All participants were observed until Week 40 after the first treatment irrespective of whether they received reinjection or not
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Period Title: First Treatment Phase (TP)
Started 78 74
Completed 74 73
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             3             1
Period Title: Second TP
Started 34 [1] 66 [1]
Completed 34 63
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             0             2
[1]
Only participants who received a second treatment entered this phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. Total of all reporting groups
Overall Number of Baseline Participants 78 74 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 74 participants 152 participants
36.2  (10.05) 34.7  (11.69) 35.5  (10.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 74 participants 152 participants
Female
61
  78.2%
55
  74.3%
116
  76.3%
Male
17
  21.8%
19
  25.7%
36
  23.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian-Japanese Heritage Number Analyzed 78 participants 74 participants 152 participants
78 74 152
1.Primary Outcome
Title Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Measure Type: Number
Unit of Measure: percentage of participants
96.2 45.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BTX 50 U in First and Second TPs, Placebo in First TP; BTX 50 U in Second TP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 50.2
Confidence Interval (2-Sided) 95%
38.1 to 62.3
Estimation Comments Percentage difference was estimated as BTX 50 U minus placebo.
2.Secondary Outcome
Title Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.
Time Frame Weeks 1, 8 ,12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 93.6 52.7
Week 8 94.9 48.6
Week 12 89.7 62.2
Week 16 87.2 32.4
Week 20 74.4 20.3
Week 24 56.4 9.5
3.Secondary Outcome
Title Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
Time Frame Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
Week 0 (Baseline) 125.16  (85.366) 137.45  (128.215)
Week 1 17.58  (21.725) 81.30  (117.296)
Week 4 18.90  (36.500) 82.92  (98.940)
Week 8 15.47  (24.471) 80.43  (121.172)
Week 12 17.99  (28.380) 68.31  (67.493)
Week 16 18.60  (26.827) 115.44  (157.710)
Week 20 24.90  (31.793) 127.30  (161.965)
Week 24 44.27  (71.909) 135.36  (159.123)
4.Secondary Outcome
Title Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.
Time Frame Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: percent change
Week 1 -82.4  (24.40) -44.5  (53.32)
Week 4 -87.0  (16.00) -34.3  (55.77)
Week 8 -84.8  (25.07) -37.3  (51.64)
Week 12 -81.0  (37.10) -33.6  (80.24)
Week 16 -78.8  (40.39) -5.2  (109.55)
Week 20 -71.2  (43.99) 1.9  (108.77)
Week 24 -55.6  (69.41) 8.6  (105.13)
5.Secondary Outcome
Title Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase
Hide Description The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.
Time Frame Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Measure Type: Number
Unit of Measure: percentage of participants
Week 1, n=78, 74 32.1 8.1
Week 4, n=78, 73 61.5 13.7
Week 8, n=78, 73 66.7 12.3
Week 12, n=76, 73 57.9 13.7
Week 16, n=76, 73 57.9 9.6
Week 20, n=75, 73 48.0 9.6
Week 24, n=76, 72 38.2 6.9
Week 28, n=76, 71 36.8 4.2
Week 32, n=74, 71 32.4 4.2
Week 36, n=75, 70 30.7 4.3
Week 40, n=74, 70 27.0 4.3
6.Secondary Outcome
Title Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -1.1  (0.84) -0.5  (0.71)
Week 4, n=78, 73 -1.6  (0.80) -0.5  (0.84)
Week 8, n=78, 73 -1.7  (0.75) -0.5  (0.77)
Week 12, n=76, 73 -1.6  (0.77) -0.7  (0.80)
Week 16, n=76, 73 -1.6  (0.75) -0.6  (0.71)
Week 20, n=65, 24 -1.6  (0.72) -1.0  (0.78)
Week 24, n=56, 15 -1.6  (0.78) -1.1  (0.88)
Week 28, n=42, 6 -1.7  (0.55) -1.5  (0.55)
Week 32, n=40, 7 -1.6  (0.63) -1.6  (0.79)
Week 36, n=41, 7 -1.6  (0.63) -1.6  (0.79)
Week 40, n=40, 7 -1.5  (0.64) -1.6  (0.79)
7.Secondary Outcome
Title Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -5.4  (4.61) -1.8  (3.49)
Week 4, n=78, 73 -6.6  (4.82) -1.7  (3.66)
Week 8, n=78, 73 -6.9  (4.72) -2.0  (3.89)
Week 12, n=76, 73 -6.9  (4.41) -2.5  (4.26)
Week 16, n=76, 73 -6.9  (4.48) -2.5  (4.25)
Week 20, n=65, 24 -6.7  (4.34) -3.1  (4.37)
Week 24, n=56, 15 -6.9  (4.77) -3.1  (4.53)
Week 28, n=42, 6 -7.3  (4.66) -5.0  (4.73)
Week 32, n=40, 7 -7.1  (4.69) -3.9  (6.47)
Week 36, n=41, 7 -6.9  (4.82) -4.1  (5.70)
Week 40, n=40, 7 -6.5  (4.75) -4.4  (5.19)
8.Secondary Outcome
Title Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=8, 74 -0.9  (0.97) -0.2  (0.95)
Week 4, n=78, 73 -1.2  (1.01) -0.2  (0.90)
Week 8, n=78, 73 -1.3  (1.16) -0.3  (0.87)
Week 12, n=76, 73 -1.3  (1.04) -0.4  (0.96)
Week 16, n=76, 73 -1.3  (0.99) -0.3  (1.04)
Week 20, n=65, 24 -1.2  (1.07) -0.5  (1.06)
Week 24, n=56, 15 -1.3  (1.19) -0.6  (1.06)
Week 28, n=42, 6 -1.5  (1.13) -1.2  (0.98)
Week 32, n=40, 7 -1.4  (1.08) -0.7  (1.50)
Week 36, n=41, 7 -1.3  (1.11) -0.7  (1.50)
Week 40, n=40, 7 -1.3  (1.06) -0.9  (1.21)
9.Secondary Outcome
Title Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -1.8  (1.76) -0.6  (1.40)
Week 4, n=78, 73 -2.2  (1.67) -0.5  (1.33)
Week 8, n=78, 73 -2.4  (1.74) -0.6  (1.44)
Week 12, n=76, 73 -2.4  (1.63) -0.9  (1.45)
Week 16, n=76, 73 -2.4  (1.63) -1.0  (1.38)
Week 20, n=65, 24 -2.3  (1.56) -1.1  (1.35)
Week 24, n=56, 15 -2.4  (1.68) -1.2  (1.57)
Week 28, n=42, 6 -2.5  (1.69) -1.5  (1.52)
Week 32, n=40, 7 -2.4  (1.66) -1.4  (1.62)
Week 36, n=41, 7 -2.4  (1.77) -1.3  (1.38)
Week 40, n=40, 7 -2.1  (1.76) -1.6  (1.62)
10.Secondary Outcome
Title Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -1.4  (1.62) -0.5  (1.37)
Week 4, n=78, 73 -1.6  (1.60) -0.6  (1.33)
Week 8, n=78, 73 -1.7  (1.50) -0.7  (1.38)
Week 12, n=76, 73 -1.7  (1.51) -0.8  (1.45)
Week 16, n=76, 73 -1.7  (1.52) -0.7  (1.45)
Week 20, n=65, 24 -1.7  (1.56) -1.0  (1.53)
Week 24, n=56, 15 -1.9  (1.67) -0.8  (1.52)
Week 28, n=42, 6 -1.8  (1.59) -1.3  (1.63)
Week 32, n=40, 7 -1.8  (1.72) -1.1  (2.19)
Week 36, n=41, 7 -1.7  (1.76) -1.1  (2.19)
Week 40, n=40, 7 -1.7  (1.71) -1.0  (1.91)
11.Secondary Outcome
Title Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.5  (0.64) -0.2  (0.57)
Week 4, n=78, 73 -0.7  (0.75) -0.1  (0.76)
Week 8, n=78, 73 -0.7  (0.79) -0.1  (0.69)
Week 12, n=76, 73 -0.7  (0.79) -0.2  (0.74)
Week 16, n=76, 73 -0.6  (0.78) -0.1  (0.71)
Week 20, n=65, 24 -0.7  (0.73) -0.3  (0.82)
Week 24, n=56, 15 -0.7  (0.78) -0.2  (0.86)
Week 28, n=42, 6 -0.8  (0.73) -0.5  (0.55)
Week 32, n=40, 7 -0.8  (0.66) -0.1  (1.46)
Week 36, n=41, 7 -0.8  (0.82) -0.4  (0.79)
Week 40, n=40, 7 -0.7  (0.65) -0.6  (0.53)
12.Secondary Outcome
Title Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.4  (0.85) -0.1  (0.61)
Week 4, n=78, 73 -0.4  (0.83) -0.1  (0.64)
Week 8, n=78, 73 -0.4  (0.83) -0.2  (0.68)
Week 12, n=76, 13 -0.4  (0.81) -0.2  (0.80)
Week 16, n=76, 73 -0.4  (0.88) -0.2  (0.84)
Week 20, n=65, 24 -0.4  (0.81) -0.1  (0.74)
Week 24, n=56, 15 -0.4  (0.80) -0.1  (0.70)
Week 28, n=42, 6 -0.4  (0.79) -0.3  (0.82)
Week 32, n=40, 7 -0.4  (0.81) -0.3  (0.76)
Week 36, n=41, 7 -0.4  (0.80) -0.3  (0.76)
Week 40, n=40, 7 -0.4  (0.81) -0.3  (0.76)
13.Secondary Outcome
Title Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.3  (0.65) -0.1  (0.48)
Week 4, n=78, 73 -0.4  (0.69) -0.1  (0.71)
Week 8, n=78, 73 -0.4  (0.69) -0.2  (0.62)
Week 12, n=76, 73 -0.4  (0.62) -0.1  (0.65)
Week 16, n=76, 73 -0.4  (0.66) -0.1  (0.63)
Week 20, n=65, 24 -0.4  (0.63) -0.1  (0.61)
Week 24, n=56, 15 -0.3  (0.69) -0.2  (0.56)
Week 28, n=42, 6 -0.3  (0.64) -0.2  (0.41)
Week 32, n=40, 7 -0.3  (0.56) -0.1  (0.38)
Week 36, n=41, 7 -0.3  (0.57) -0.3  (0.49)
Week 40, n=40, 7 -0.3  (0.64) -0.1  (0.38)
14.Secondary Outcome
Title Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 0.0  (0.47) 0.0  (0.39)
Week 4, n=78, 73 -0.1  (0.33) 0.0  (0.33)
Week 8, n=78, 73 -0.1  (0.48) 0.0  (0.46)
Week 12, n=76, 73 -0.1  (0.42) -0.1  (0.40)
Week 16, n=76, 73 -0.1  (0.40) 0.0  (0.39)
Week 20, n=65, 24 -0.1  (0.51) 0.2  (0.38)
Week 24, n=56, 15 0.0  (0.42) 0.1  (0.26)
Week 28, n=42, 6 0.0  (0.31) 0.0  (0.00)
Week 32, n=40, 7 -0.1  (0.22) 0.0  (0.00)
Week 36, n=41, 7 0.0  (0.27) 0.0  (0.00)
Week 40, n=40, 7 -0.1  (0.32) 0.0  (0.00)
15.Secondary Outcome
Title Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.9  (0.94) -0.2  (0.92)
Week 4, n=78, 73 -1.1  (1.00) -0.2  (0.87)
Week 8, n=78, 73 -1.2  (1.05) -0.3  (0.85)
Week 12, n=76, 73 -1.2  (1.02) -0.3  (0.91)
Week 16, n=76, 73 -1.2  (0.96) -0.3  (0.94)
Week 20, n=65, 24 -1.2  (1.02) -0.6  (0.92)
Week 24, n=56, 15 -1.3  (1.06) -0.7  (0.98)
Week 28, n=42, 6 -1.4  (1.04) -1.2  (0.98)
Week 32, n=40, 7 -1.4  (1.00) -0.7  (1.50)
Week 36, n=41, 7 -1.3  (1.01) -0.7  (1.50)
Week 40, n=40, 7 -1.2  (0.97) -0.9  (1.21)
16.Secondary Outcome
Title Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.6  (1.01) -0.2  (0.77)
Week 4, n=78, 73 -0.8  (1.02) -0.2  (0.76)
Week 8, n=78, 73 -0.8  (1.03) -0.2  (0.75)
Week 12, n=76, 73 -0.8  (0.98) -0.4  (0.89)
Week 16, n=76, 73 -0.8  (0.97) -0.4  (0.86)
Week 20, n=65, 24 -0.8  (0.96) -0.3  (0.75)
Week 24, n=56, 15 -0.8  (1.05) -0.4  (0.91)
Week 28, n=42, 6 -0.9  (0.92) -0.5  (0.84)
Week 32, n=40, 7 -0.9  (0.97) -0.6  (0.79)
Week 36, n=41, 7 -0.9  (0.97) -0.6  (0.79)
Week 40, n=40, 7 -0.8  (1.04) -0.6  (0.79)
17.Secondary Outcome
Title Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -1.2  (1.03) -0.5  (0.88)
Week 4, n=78, 73 -1.5  (0.92) -0.3  (0.90)
Week 8, n=78, 73 -1.6  (1.00) -0.4  (1.01)
Week 12, n=76, 73 -1.6  (1.02) -0.5  (0.90)
Week 16, n=76, 73 -1.6  (0.97) -0.6  (0.91)
Week 20, n=65, 24 -1.5  (0.87) -0.8  (0.78)
Week 24, n=56, 15 -1.5  (0.91) -0.8  (1.08)
Week 28, n=42, 6 -1.6  (1.06) -1.0  (0.89)
Week 32, n=40, 7 -1.5  (0.96) -0.9  (1.21)
Week 36, n=41, 7 -1.5  (1.00) -0.7  (1.11)
Week 40, n=40, 7 -1.3  (0.94) -1.0  (1.15)
18.Secondary Outcome
Title Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.8  (0.94) -0.2  (0.80)
Week 4, n=78, 73 -0.9  (0.92) -0.3  (0.82)
Week 8, n=78, 73 -1.0  (0.92) -0.3  (0.86)
Week 12, n=76, 73 -1.0  (0.94) -0.4  (0.84)
Week 16, n=76, 73 -1.0  (0.95) -0.4  (0.86)
Week 20, n=65, 24 -1.0  (0.93) -0.3  (0.75)
Week 24, n=56, 15 -1.1  (0.97) -0.1  (0.70)
Week 28, n=42, 6 -1.1  (0.98) -0.5  (0.84)
Week 32, n=40, 7 -1.1  (1.02) -0.4  (1.51)
Week 36, n=41, 7 -1.0  (1.02) -0.4  (0.98)
Week 40, n=40, 7 -1.1  (0.99) -0.4  (0.98)
19.Secondary Outcome
Title Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.6  (0.94) -0.3  (0.85)
Week 4, n=78, 73 -0.7  (1.00) -0.3  (0.85)
Week 8, n=78, 73 -0.7  (0.91) -0.4  (0.86)
Week 12, n=76, 73 -0.7  (0.94) -0.4  (0.91)
Week 16, n=76, 73 -0.7  (0.94) -0.4  (0.90)
Week 20, n=65, 24 -0.7  (0.94) -0.7  (1.16)
Week 24, n=56, 15 -0.7  (0.94) -0.7  (1.10)
Week 28, n=42, 6 -0.7  (0.87) -0.8  (0.98)
Week 32, n=40, 7 -0.7  (0.92) -0.7  (0.95)
Week 36, n=41, 7 -0.7  (0.99) -0.7  (1.38)
Week 40, n=40, 7 -0.7  (0.94) -0.6  (1.13)
20.Secondary Outcome
Title Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.5  (0.64) -0.2  (0.57)
Week 4, n=78, 73 -0.7  (0.75) -0.1  (0.76)
Week 8, n=78, 73 -0.7  (0.79) -0.1  (0.69)
Week 12, n=76, 73 -0.7  (0.79) -0.2  (0.74)
Week 16, n=76, 73 -0.6  (0.78) -0.1  (0.71)
Week 20, n=65, 24 -0.7  (0.73) -0.3  (0.82)
Week 24, n=56, 15 -0.7  (0.78) -0.2  (0.86)
Week 28, n=42, 6 -0.8  (0.73) -0.5  (0.55)
Week 32, n=40, 7 -0.8  (0.66) -0.1  (1.46)
Week 36, n=41, 7 -0.8  (0.82) -0.4  (0.79)
Week 40, n=40, 7 -0.7  (0.65) -0.6  (0.53)
21.Secondary Outcome
Title Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.3  (0.58) -0.1  (0.42)
Week 4, n=78, 73 -0.3  (0.57) -0.1  (0.45)
Week 8, n=78, 73 -0.3  (0.54) -0.1  (0.51)
Week 12, n=76, 73 -0.3  (0.54) -0.1  (0.55)
Week 16, n=76, 73 -0.3  (0.54) -0.1  (0.60)
Week 20, n=65, 24 -0.3  (0.52) -0.1  (0.41)
Week 24, n=56, 15 -0.3  (0.53) -0.1  (0.46)
Week 28, n=42, 6 -0.3  (0.50) -0.2  (0.41)
Week 32, n=40, 7 -0.3  (0.51) -0.1  (0.38)
Week 36, n=41, 7 -0.2  (0.49) -0.1  (0.38)
Week 40, n=40, 7 -0.3  (0.51) -0.1  (0.38)
22.Secondary Outcome
Title Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.2  (0.40) 0.0  (0.31)
Week 4, n=78, 73 -0.1  (0.39) -0.1  (0.33)
Week 8, n=78, 73 -0.1  (0.42) -0.1  (0.33)
Week 12, n=76, 73 -0.1  (0.39) -0.1  (0.40)
Week 16, n=76, 73 -0.1  (0.47) 0.0  (0.37)
Week 20, n=65, 24 -0.1  (0.39) 0.0  (0.36)
Week 24, n=56, 15 -0.1  (0.41) 0.0  (0.38)
Week 28, n=42, 6 -0.1  (0.40) -0.2  (0.41)
Week 32, n=40, 7 -0.1  (0.40) -0.1  (0.38)
Week 36, n=41, 7 -0.1  (0.40) -0.1  (0.38)
Week 40, n=40, 7 -0.1  (0.40) -0.1  (0.38)
23.Secondary Outcome
Title Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 -0.3  (0.65) -0.1  (0.48)
Week 4, n=78, 73 -0.4  (0.69) -0.1  (0.71)
Week 8, n=78, 73 -0.4  (0.69) -0.2  (0.62)
Week 12, n=76, 73 -0.4  (0.62) -0.1  (0.65)
Week 16, n=76, 73 -0.4  (0.66) -0.1  (0.63)
Week 20, n=65, 24 -0.4  (0.63) -0.1  (0.61)
Week 24, n=56, 15 -0.3  (0.69) -0.2  (0.56)
Week 28, n=42, 6 -0.3  (0.64) -0.2  (0.41)
Week 32, n=40, 7 -0.3  (0.56) -0.1  (0.38)
Week 36, n=41, 7 -0.3  (0.57) -0.3  (0.49)
Week 40, n=40, 7 -0.3  (0.64) -0.1  (0.38)
24.Secondary Outcome
Title Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase
Hide Description The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.
Time Frame Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=78, 74 1.8  (1.28) 0.6  (0.95)
Week 4, n=78, 73 2.6  (10.7) 0.5  (1.05)
Week 8, n=78, 73 2.7  (1.16) 0.3  (0.96)
Week 12, n=76, 73 2.6  (1.33) 0.4  (0.86)
Week 16, n=76, 73 2.6  (1.23) 0.4  (0.83)
Week 20, n=65, 24 2.6  (1.14) 0.5  (1.06)
Week 24, n=56, 15 2.5  (1.21) 0.9  (1.22)
Week 28, n=42, 6 2.9  (0.88) 1.0  (1.26)
Week 32, n=40, 7 2.6  (1.37) 1.3  (1.38)
Week 36, n=41, 7 2.5  (1.31) 1.0  (1.63)
Week 40, n=40, 7 2.4  (1.35) 1.1  (1.46)
25.Secondary Outcome
Title Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.
Time Frame Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
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Hide Analysis Population Description
FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
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Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 97.1 92.3 93.9
Week 8 94.1 96.9 96.0
Week 12 97.1 96.9 97.0
Week 16 91.2 95.4 93.9
26.Secondary Outcome
Title Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
Time Frame Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
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FAS2 (LOCF dataset)
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: mg
Baseline (Week 0) 84.50  (92.872) 145.39  (163.635) 124.48  (145.725)
Week 4 6.69  (7.513) 17.25  (35.386) 13.62  (29.363)
Week 8 11.37  (26.561) 17.82  (36.049) 15.61  (33.102)
Week 12 15.22  (27.057) 14.20  (20.411) 14.55  (22.778)
Week 16 12.87  (15.458) 14.49  (21.217) 13.94  (19.366)
27.Secondary Outcome
Title Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase
Hide Description A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.
Time Frame Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
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[Not Specified]
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: percent change
Week 4 -89.6  (15.20) -84.6  (31.18) -86.3  (26.80)
Week 8 -86.2  (16.76) -84.4  (33.85) -85.0  (29.04)
Week 12 -82.6  (18.43) -87.6  (21.14) -85.9  (20.30)
Week 16 -77.6  (32.23) -84.5  (24.87) -82.1  (27.65)
28.Secondary Outcome
Title Percentage of Responders Assessed by the HDSS in the Second Treatment Phase
Hide Description The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.
Time Frame Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
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Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Measure Type: Number
Unit of Measure: percentage of participants
Week 4, n=34, 65, 99 11.8 47.7 35.4
Week 8, n=34, 65, 99 14.7 43.1 33.3
Week 12, n=34, 64, 98 8.8 48.4 34.7
Week 16, n=34, 62, 96 2.9 43.5 29.2
Week 20, n=20, 56, 76 0 37.5 27.6
Week 24, n=10, 49, 59 0 36.7 30.5
29.Secondary Outcome
Title Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase
Hide Description The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
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Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.9  (0.61) -1.5  (0.79) -1.3  (0.79)
Week 8, n=34, 65, 99 -0.9  (0.65) -1.4  (0.70) -1.2  (0.72)
Week 12, n=34, 64, 98 -0.8  (0.64) -1.4  (0.75) -1.2  (0.77)
Week 16, n=34, 62, 96 -0.6  (0.54) -1.3  (0.80) -1.1  (0.78)
Week 20, n=20, 56, 76 -0.6  (0.51) -1.2  (0.79) -1.0  (0.77)
Week 24, n=10, 49, 59 -0.3  (0.67) -1.1  (0.84) -0.9  (0.86)
30.Secondary Outcome
Title Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
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FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -2.6  (2.65) -4.0  (4.21) -3.6  (3.79)
Week 8, n=34, 65, 99 -2.4  (3.18) -4.0  (4.28) -3.4  (4.00)
Week 12, n=34, 64, 98 -2.0  (2.72) -3.9  (4.04) -3.2  (3.74)
Week 16, n=34, 62, 96 -1.9  (2.48) -3.7  (4.46) -3.0  (3.96)
Week 20, n=20, 56, 76 -1.3  (1.41) -3.3  (4.03) -2.8  (3.63)
Week 24, n=10, 49, 59 -0.7  (3.20) -3.3  (4.55) -2.8  (4.43)
31.Secondary Outcome
Title Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
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Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.5  (0.90) -0.8  (0.86) -0.7  (0.88)
Week 8, n=34, 65, 99 -0.6  (1.04) -0.8  (0.89) -0.8  (0.95)
Week 12, n=34, 64, 98 -0.5  (0.99) -0.8  (0.84) -0.7  (0.91)
Week 16, n=34, 62, 96 -0.4  (0.89) -0.7  (0.93) -0.6  (0.92)
Week 20, n=20, 56, 76 -0.3  (0.66) -0.8  (0.84) -0.6  (0.81)
Week 24, n=10, 49, 59 -0.1  (1.10) -0.8  (0.85) -0.7  (0.92)
32.Secondary Outcome
Title Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
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Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -1.1  (1.07) -1.4  (1.34) -1.3  (1.26)
Week 8, n=34, 65, 99 -0.9  (1.08) -1.3  (1.36) -1.2  (1.28)
Week 12, n=34, 64, 98 -0.8  (1.06) -1.3  (1.20) -1.2  (1.17)
Week 16, n=34, 62, 96 -0.6  (1.07) -1.2  (1.39) -1.0  (1.31)
Week 20, n=20, 56, 76 -0.4  (0.82) -1.0  (1.33) -0.9  (1.25)
Week 24, n=10, 49, 59 -0.6  (1.07) -1.1  (1.48) -1.0  (1.42)
33.Secondary Outcome
Title Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.6  (0.82) -0.7  (0.97) -0.6  (0.92)
Week 8, n=34, 65, 99 -0.4  (0.96) -0.7  (1.02) -0.6  (1.01)
Week 12, n=34, 64, 98 -0.4  (0.82) -0.7  (1.03) -0.6  (0.96)
Week 16, n=34, 62, 96 -0.5  (0.83) -0.6  (1.01) -0.6  (0.95)
Week 20, n=20, 56, 76 -0.3  (0.47) -0.6  (0.89) -0.5  (0.81)
Week 24, n=10, 49, 59 -0.2  (0.63) -0.5  (1.02) -0.5  (0.97)
34.Secondary Outcome
Title Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.3  (0.51) -0.6  (0.83) -0.5  (0.75)
Week 8, n=34, 65, 99 -0.2  (0.65) -0.5  (0.85) -0.4  (0.80)
Week 12, n=34, 64, 98 -0.1  (0.56) -0.5  (0.93) -0.4  (0.83)
Week 16, n=34, 62, 96 -0.2  (0.43) -0.5  (0.84) -0.4  (0.74)
Week 20, n=20, 56, 76 -0.2  (0.37) -0.4  (0.78) -0.4  (0.71)
Week 24, n=10, 49, 59 -0.1  (0.57) -0.4  (0.91) -0.4  (0.87)
35.Secondary Outcome
Title Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.1  (0.29) -0.3  (0.77) -0.2  (0.65)
Week 8, n=34, 65, 99 0.0  (0.30) -0.3  (0.81) -0.2  (0.69)
Week 12, n=34, 64, 98 -0.1  (0.29) -0.3  (0.78) -0.2  (0.66)
Week 16, n=34, 62, 96 0.0  (0.30) -0.3  (0.89) -0.2  (0.75)
Week 20, n=20, 56, 76 0.0  (0.30) -0.3  (0.73) -0.2  (0.63)
Week 24, n=10, 49, 59 0.2  (0.63) -0.3  (0.87) -0.2  (0.85)
36.Secondary Outcome
Title Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.1  (0.50) -0.3  (0.59) -0.2  (0.56)
Week 8, n=34, 65, 99 -0.1  (0.36) -0.3  (0.62) -0.2  (0.55)
Week 12, n=34, 64, 98 0.0  (0.30) -0.3  (0.60) -0.2  (0.52)
Week 16, n=34, 62, 96 -0.1  (0.29) -0.2  (0.73) -0.2  (0.62)
Week 20, n=20, 56, 76 -0.1  (0.31) -0.2  (0.69) -0.2  (0.61)
Week 24, n=10, 49, 59 0.1  (0.32) -0.2  (0.73) -0.1  (0.68)
37.Secondary Outcome
Title Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.1  (0.55) -0.1  (0.30) -0.1  (0.40)
Week 8, n=34, 65, 99 -0.1  (0.56) -0.1  (0.35) -0.1  (0.43)
Week 12, n=34, 64, 98 -0.1  (0.56) 0.0  (0.38) -0.1  (0.45)
Week 16, n=34, 62, 96 -0.1  (0.50) 0.0  (0.40) -0.1  (0.44)
Week 20, n=20, 56, 76 -0.1  (0.51) -0.1  (0.32) -0.1  (0.38)
Week 24, n=10, 49, 59 0.1  (0.57) -0.1  (0.31) -0.1  (0.37)
38.Secondary Outcome
Title Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.4  (0.66) -0.8  (0.79) -0.6  (0.76)
Week 8, n=34, 65, 99 -0.5  (0.71) -0.8  (0.81) -0.7  (0.78)
Week 12, n=34, 64, 98 -0.3  (0.84) -0.7  (0.76) -0.6  (0.81)
Week 16, n=34, 62, 96 -0.3  (0.67) -0.7  (0.83) -0.5  (0.79)
Week 20, n=20, 56, 76 -0.3  (0.44) -0.7  (0.81) -0.6  (0.75)
Week 24, n=10, 49, 59 -0.2  (0.63) -0.7  (0.85) -0.6  (0.83)
39.Secondary Outcome
Title Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.3  (0.47) -0.4  (0.60) -0.4  (0.56)
Week 8, n=34, 65, 99 -0.3  (0.57) -0.3  (0.59) -0.3  (0.58)
Week 12, n=34, 64, 98 -0.3  (0.51) -0.3  (0.49) -0.3  (0.50)
Week 16, n=34, 62, 96 -0.3  (0.51) -0.3  (0.57) -0.3  (0.55)
Week 20, n=20, 56, 76 -0.2  (0.41) -0.3  (0.65) -0.3  (0.60)
Week 24, n=10, 49, 59 -0.4  (0.52) -0.3  (0.60) -0.3  (0.59)
40.Secondary Outcome
Title Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.7  (0.71) -1.0  (0.93) -0.9  (0.87)
Week 8, n=34, 65, 99 -0.6  (0.69) -1.0  (0.93) -0.8  (0.86)
Week 12, n=34, 64, 98 -0.6  (0.66) -1.0  (0.89) -0.9  (0.85)
Week 16, n=34, 62, 96 -0.4  (0.70) -0.9  (1.03) -0.7  (0.96)
Week 20, n=20, 56, 76 -0.2  (0.52) -0.8  (0.94) -0.6  (0.88)
Week 24, n=10, 49, 59 -0.2  (0.63) -0.8  (1.08) -0.7  (1.04)
41.Secondary Outcome
Title Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.3  (0.59) -0.4  (0.66) -0.4  (0.63)
Week 8, n=34, 65, 99 -0.2  (0.70) -0.4  (0.71) -0.4  (0.71)
Week 12, n=34, 64, 98 -0.3  (0.62) -0.4  (0.68) -0.3  (0.66)
Week 16, n=34, 62, 96 -0.3  (0.57) -0.4  (0.69) -0.3  (0.65)
Week 20, n=20, 56, 76 -0.2  (0.37) -0.3  (0.67) -0.3  (0.61)
Week 24, n=10, 49, 59 0.0  (0.00) -0.3  (0.75) -0.3  (0.69)
42.Secondary Outcome
Title Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.3  (0.45) -0.3  (0.54) -0.3  (0.51)
Week 8, n=34, 65, 99 -0.2  (0.52) -0.3  (0.56) -0.3  (0.55)
Week 12, n=34, 64, 98 -0.2  (0.46) -0.3  (0.60) -0.2  (0.55)
Week 16, n=34, 62, 96 -0.2  (0.48) -0.3  (0.57) -0.2  (0.54)
Week 20, n=20, 56, 76 -0.2  (0.37) -0.3  (0.53) -0.3  (0.49)
Week 24, n=10, 49, 59 -0.2  (0.63) -0.2  (0.54) -0.2  (0.55)
43.Secondary Outcome
Title Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.3  (0.51) -0.6  (0.83) -0.5  (0.75)
Week 8, n=34, 65, 99 -0.2  (0.65) -0.5  (0.85) -0.4  (0.80)
Week 12, n=34, 64, 98 -0.1  (0.56) -0.5  (0.93) -0.4  (0.83)
Week 16, n=34, 62, 96 -0.2  (0.43) -0.5  (0.84) -0.4  (0.74)
Week 20, n=20, 56, 76 -0.2  (0.37) -0.4  (0.78) -0.4  (0.71)
Week 24, n=10, 49, 59 -0.1  (0.57) -0.4  (0.91) -0.4  (0.87)
44.Secondary Outcome
Title Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 0.0  (0.00) -0.2  (0.49) -0.1  (0.40)
Week 8, n=34, 65, 99 0.0  (0.17) -0.2  (0.51) -0.1  (0.43)
Week 12, n=34, 64, 98 0.0  (0.17) -0.2  (0.41) -0.1  (0.45)
Week 16, n=34, 62, 96 0.0  (0.17) -0.2  (0.52) -0.1  (0.44)
Week 20, n=20, 56, 76 0.1  (0.22) -0.1  (0.41) -0.1  (0.38)
Week 24, n=10, 49, 59 0.2  (0.63) -0.1  (0.58) -0.1  (0.60)
45.Secondary Outcome
Title Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.1  (0.29) -0.1  (0.43) -0.1  (0.39)
Week 8, n=34, 65, 99 -0.1  (0.24) -0.2  (0.44) -0.1  (0.39)
Week 12, n=34, 64, 98 -0.1  (0.24) -0.2  (0.49) -0.1  (0.42)
Week 16, n=34, 62, 96 -0.1  (0.24) -0.2  (0.50) -0.1  (0.43)
Week 20, n=20, 56, 76 -0.1  (0.22) -0.2  (0.46) -0.1  (0.41)
Week 24, n=10, 49, 59 0.0  (0.00) -0.1  (0.46) -0.1  (0.42)
46.Secondary Outcome
Title Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
Hide Description The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time Frame Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 -0.1  (0.50) -0.3  (0.59) -0.2  (0.56)
Week 8, n=34, 65, 99 -0.1  (0.36) -0.3  (0.62) -0.2  (0.55)
Week 12, n=34, 64, 98 0.0  (0.30) -0.3  (0.60) -0.2  (0.52)
Week 16, n=34, 62, 96 -0.1  (0.29) -0.2  (0.73) -0.2  (0.62)
Week 20, n=20, 56, 76 -0.1  (0.31) -0.2  (0.69) -0.2  (0.61)
Week 24, n=10, 49, 59 0.1  (0.32) -0.2  (0.73) -0.1  (0.68)
47.Secondary Outcome
Title Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase
Hide Description Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.
Time Frame Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP Total
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Overall Number of Participants Analyzed 34 65 99
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=34, 65, 99 3.2  (0.88) 2.8  (1.10) 2.9  (1.04)
Week 8, n=34, 65, 99 3.0  (1.14) 2.8  (1.09) 2.9  (1.11)
Week 12, n=34, 64, 98 2.8  (1.14) 2.7  (1.27) 2.7  (1.22)
Week 16, n=34, 62, 96 2.6  (1.35) 2.6  (1.36) 2.6  (1.35)
Week 20, n=20, 56, 76 2.3  (1.29) 2.3  (1.46) 2.3  (1.41)
Week 24, n=10, 49, 59 1.7  (1.34) 2.1  (1.52) 2.0  (1.49)
48.Secondary Outcome
Title Duration of Effect
Hide Description Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.
Time Frame Up to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
FAS1
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description:
Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Overall Number of Participants Analyzed 78 74
Median (95% Confidence Interval)
Unit of Measure: days
273.0 [1] 
(171.0 to NA)
35.0
(28.0 to 56.0)
[1]
The upper limit of the 95% CI for the median cannot be estimated because the follow-up duration is limited.
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.
 
Arm/Group Title BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Hide Arm/Group Description Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
All-Cause Mortality
BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Affected / at Risk (%) Affected / at Risk (%)
Total   1/144 (0.69%)   1/74 (1.35%) 
Gastrointestinal disorders     
Colitis  1  0/144 (0.00%)  1/74 (1.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian neoplasm  1  1/144 (0.69%)  0/74 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BTX 50 U in First and Second TPs Placebo in First TP; BTX 50 U in Second TP
Affected / at Risk (%) Affected / at Risk (%)
Total   23/144 (15.97%)   9/74 (12.16%) 
Infections and infestations     
Nasopharyngitis  1  23/144 (15.97%)  9/74 (12.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01128738     History of Changes
Other Study ID Numbers: 114078
First Submitted: May 20, 2010
First Posted: May 24, 2010
Results First Submitted: March 29, 2012
Results First Posted: April 25, 2012
Last Update Posted: June 8, 2015