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Study of Glycopyrronium in Axillary Hyperhydrosis

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ClinicalTrials.gov Identifier: NCT02530281
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

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 Drug: glycopyrronium Topical Wipes
Other: Vehicle
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description Glycopyrronium Topical Wipes Glycopyrronium Topical Wipes, Vehicle
Period Title: Overall Study
Started 229 115
Completed 208 112
Not Completed 21 3
Arm/Group Title Glycopyrronium Vehicle Total
Hide Arm/Group Description glycopyrronium Topical Wipes glycopyrronium Topical Wipes, Vehicle Total of all reporting groups
Overall Number of Baseline Participants 229 115 344
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 115 participants 344 participants
<=18 years
24
  10.5%
10
   8.7%
34
   9.9%
Between 18 and 65 years
204
  89.1%
101
  87.8%
305
  88.7%
>=65 years
1
   0.4%
4
   3.5%
5
   1.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 115 participants 344 participants
Female
130
  56.8%
60
  52.2%
190
  55.2%
Male
99
  43.2%
55
  47.8%
154
  44.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 115 participants 344 participants
Hispanic or Latino
46
  20.1%
23
  20.0%
69
  20.1%
Not Hispanic or Latino
183
  79.9%
92
  80.0%
275
  79.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 115 participants 344 participants
American Indian or Alaska Native
2
   0.9%
0
   0.0%
2
   0.6%
Asian
4
   1.7%
0
   0.0%
4
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.7%
2
   0.6%
Black or African American
31
  13.5%
16
  13.9%
47
  13.7%
White
182
  79.5%
94
  81.7%
276
  80.2%
More than one race
10
   4.4%
3
   2.6%
13
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
Hide Description

The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:

  1. During the past 24 hours, did you have any underarm sweating? (Yes or No)
  2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)
  3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)
  4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: percent of subjects
52.8 28.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Primary Outcome
Title Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Hide Description Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject’s axilla with the arm down by the subject’s side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 229 115
Least Squares Mean (Standard Deviation)
Unit of Measure: mg/5 min
-102.00  (176.136) -100.34  (172.276)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.065
Comments [Not Specified]
Method ANCOVA
Comments Ranked ANCOVA
3.Primary Outcome
Title Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Hide Description [Not Specified]
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 229 115
Median (Inter-Quartile Range)
Unit of Measure: mg/5 min
-80.79
(-148.78 to -40.15)
-65.81
(-105.67 to -27.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.065
Comments [Not Specified]
Method ANCOVA
Comments Ranked ANCOVA
4.Primary Outcome
Title Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Hide Description [Not Specified]
Time Frame Baseline - Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
Glycopyrronium Topical Wipes
Glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 220 110
Least Squares Mean (Standard Deviation)
Unit of Measure: mg/5 min
-100.56  (98.151) -88.08  (95.695)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.001
Comments [Not Specified]
Method ANCOVA
Comments Ranked ANCOVA
5.Secondary Outcome
Title Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4
Hide Description

Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects’ condition based on how it affects daily activities.

1 (Best), 2, 3, 4 (Worst)

Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: percent of subjects
56.5 23.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Hide Description [Not Specified]
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description:
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Overall Number of Participants Analyzed 229 115
Measure Type: Number
Unit of Measure: percent of subjects
72.4 53.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glycopyrronium, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame up to 35 days
Adverse Event Reporting Description The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
 
Arm/Group Title Glycopyrronium Vehicle
Hide Arm/Group Description glycopyrronium Topical Wipes glycopyrronium Topical Wipes, Vehicle
All-Cause Mortality
Glycopyrronium Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/227 (0.00%)      0/114 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glycopyrronium Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/227 (0.44%)      0/114 (0.00%)    
Eye disorders     
unilateral mydriasis   1/227 (0.44%)  1 0/114 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glycopyrronium Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/227 (29.96%)      16/114 (14.04%)    
Eye disorders     
Mydriasis   14/227 (6.17%)  0/114 (0.00%) 
Gastrointestinal disorders     
Dry Mouth   43/227 (18.94%)  4/114 (3.51%) 
General disorders     
Application Site Pain   20/227 (8.81%)  11/114 (9.65%) 
Application Site Pruritis   4/227 (1.76%)  6/114 (5.26%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Eugene A. Bauer, MD, Chief Medical Officer
Organization: Dermira, Inc.
Phone: 650-421-7202
Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT02530281     History of Changes
Other Study ID Numbers: DRM04-HH04
2015-002052-27 ( EudraCT Number )
First Submitted: August 19, 2015
First Posted: August 21, 2015
Results First Submitted: July 20, 2018
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018