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Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02479139
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hyperhidrosis
Interventions Biological: Vehicle
Biological: ANT-1207
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Hide Arm/Group Description Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Period Title: Overall Study
Started 27 22 28 21 22 25
Completed 19 12 21 14 17 19
Not Completed 8 10 7 7 5 6
Reason Not Completed
Lost to Follow-up             2             4             4             2             3             5
Withdrew Consent             5             6             1             4             1             1
Treatment Failure/Lack of Efficacy             0             0             1             0             0             0
Other Miscellaneous Reasons             1             0             1             1             1             0
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5 Total
Hide Arm/Group Description Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 27 22 28 21 22 25 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 22 participants 28 participants 21 participants 22 participants 25 participants 145 participants
32.15  (11.83) 30.18  (6.70) 32.50  (9.86) 30.48  (6.90) 32.36  (9.56) 32.64  (10.55) 31.79  (9.46)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 28 participants 21 participants 22 participants 25 participants 145 participants
18 to 35 years 19 18 19 16 13 17 102
36 to 50 years 5 4 8 5 8 7 37
>50 years 3 0 1 0 1 1 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 22 participants 28 participants 21 participants 22 participants 25 participants 145 participants
Female
16
  59.3%
12
  54.5%
17
  60.7%
14
  66.7%
11
  50.0%
12
  48.0%
82
  56.6%
Male
11
  40.7%
10
  45.5%
11
  39.3%
07
  33.3%
11
  50.0%
13
  52.0%
63
  43.4%
1.Primary Outcome
Title Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
Hide Description

The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.

GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.

The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the last observation carried forward (LOCF) approach.
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Hide Arm/Group Description:
Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Overall Number of Participants Analyzed 27 22 28 21 21 25
Measure Type: Number
Unit of Measure: percentage of participants
3.70 13.64 17.86 14.29 14.29 12.00
2.Secondary Outcome
Title Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
Hide Description

The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.

The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported.

Time Frame Baseline, Weeks 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Hide Arm/Group Description:
Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Overall Number of Participants Analyzed 27 22 28 21 21 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 29.63 13.64 21.43 9.52 28.57 16.00
Week 8 11.11 22.73 28.57 19.05 14.29 4.00
Week 12 7.41 27.27 25.00 19.05 14.29 12.00
Week 18 7.41 22.73 21.43 19.05 23.81 8.00
3.Secondary Outcome
Title Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
Hide Description

GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.

The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported.

Time Frame Baseline, Weeks 4, 8, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Hide Arm/Group Description:
Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Overall Number of Participants Analyzed 27 22 28 21 21 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 62.96 72.73 71.43 71.43 61.90 72.00
Week 8 55.56 72.73 71.43 57.14 52.38 72.00
Week 12 66.67 63.64 67.86 47.62 71.43 72.00
Week 18 51.85 54.55 64.29 47.62 61.90 76.00
Time Frame 126 Days
Adverse Event Reporting Description Safety population included all randomized patients who received at least 1 dose of double-blind investigational product.
 
Arm/Group Title Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Hide Arm/Group Description Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
All-Cause Mortality
Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/27 (3.70%)   0/22 (0.00%)   0/28 (0.00%)   0/21 (0.00%)   0/22 (0.00%)   0/25 (0.00%) 
Surgical and medical procedures             
Gastrectomy  1  1/27 (3.70%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle ANT-1207 Dose 1 ANT-1207 Dose 2 ANT-1207 Dose 3 ANT-1207 Dose 4 ANT-1207 Dose 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/22 (0.00%)   2/28 (7.14%)   0/21 (0.00%)   0/22 (0.00%)   1/25 (4.00%) 
Infections and infestations             
Nasopharyngitis  1  0/27 (0.00%)  0/22 (0.00%)  2/28 (7.14%)  0/21 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 1-877-277-8566
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02479139     History of Changes
Other Study ID Numbers: ANT-1207-HHID-205
First Submitted: June 19, 2015
First Posted: June 24, 2015
Results First Submitted: August 25, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017