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Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02129660
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : September 3, 2018
Last Update Posted : September 3, 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: Dose 1 of glycopyrrolate, 2.0% QD
Drug: Dose 2 of glycopyrrolate, 3.0% QD
Drug: Dose 1 of glycopyrronium, 2.5% QD
Drug: Dose 2 of glycopyrronium, 3.75% QD
Other: Vehicle
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description Dose 1 of glycopyrrolate Topical Wipes Dose 2 of glycopyrrolate Topical Wipes Dose 1 of glycopyrronium Topical Wipes Dose 2 of glycopyrronium Topical Wipes Vehicle Topical Wipes
Period Title: Overall Study
Started 21 20 22 20 22
Completed 19 20 21 20 20
Not Completed 2 0 1 0 2
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle Total
Hide Arm/Group Description Dose 1 of glycopyrrolate Topical Wipes Dose 2 of glycopyrrolate Topical Wipes Dose 1 of glycopyrronium Topical Wipes Dose 2 of glycopyrronium Topical Wipes Vehicle Topical Wipes Total of all reporting groups
Overall Number of Baseline Participants 21 20 22 20 22 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 22 participants 20 participants 22 participants 105 participants
<=18 years
0
   0.0%
1
   5.0%
1
   4.5%
3
  15.0%
0
   0.0%
5
   4.8%
Between 18 and 65 years
21
 100.0%
19
  95.0%
21
  95.5%
16
  80.0%
22
 100.0%
99
  94.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   1.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 22 participants 20 participants 22 participants 105 participants
Female
8
  38.1%
7
  35.0%
7
  31.8%
13
  65.0%
13
  59.1%
48
  45.7%
Male
13
  61.9%
13
  65.0%
15
  68.2%
7
  35.0%
9
  40.9%
57
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 22 participants 20 participants 22 participants 105 participants
Hispanic or Latino
1
   4.8%
1
   5.0%
3
  13.6%
0
   0.0%
0
   0.0%
5
   4.8%
Not Hispanic or Latino
20
  95.2%
19
  95.0%
19
  86.4%
20
 100.0%
22
 100.0%
100
  95.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 22 participants 20 participants 22 participants 105 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  14.3%
0
   0.0%
3
  13.6%
3
  15.0%
2
   9.1%
11
  10.5%
White
18
  85.7%
20
 100.0%
16
  72.7%
17
  85.0%
20
  90.9%
91
  86.7%
More than one race
0
   0.0%
0
   0.0%
3
  13.6%
0
   0.0%
0
   0.0%
3
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
Hide Description

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 Baseline - Week 4/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
10
  50.0%
9
  40.9%
10
  50.0%
6
  27.3%
2.Primary Outcome
Title Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Hide Description [Not Specified]
Time Frame Baseline - Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
16
  76.2%
17
  85.0%
15
  68.2%
14
  70.0%
12
  54.5%
3.Primary Outcome
Title Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Hide Description [Not Specified]
Time Frame Baseline - Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
19
  90.5%
16
  80.0%
17
  77.3%
13
  65.0%
13
  59.1%
4.Primary Outcome
Title Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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 Baseline - Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Mean (Standard Deviation)
Unit of Measure: mg/5 min
-104.20  (73.73) -58.27  (31.00) -105.28  (95.83) -72.69  (82.48) -53.85  (70.65)
5.Primary Outcome
Title Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline - Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Mean (Standard Deviation)
Unit of Measure: mg/5 min
-92.20  (74.87) -44.37  (40.92) -96.98  (103.38) -66.17  (78.96) -71.06  (64.82)
6.Secondary Outcome
Title Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Hide Description [Not Specified]
Time Frame Baseline - Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
19
  90.5%
16
  80.0%
20
  90.9%
16
  80.0%
15
  68.2%
7.Secondary Outcome
Title Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
Hide Description [Not Specified]
Time Frame Baseline - Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description:
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Overall Number of Participants Analyzed 21 20 22 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
15
  71.4%
15
  75.0%
17
  77.3%
16
  80.0%
14
  63.6%
Time Frame 6 weeks
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 Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Hide Arm/Group Description Dose 1 of glycopyrrolate Topical Wipes Dose 2 of glycopyrrolate Topical Wipes Dose 1 of glycopyrronium Topical Wipes Dose 2 of glycopyrronium Topical Wipes Vehicle Topical Wipes
All-Cause Mortality
Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose 1 of Glycopyrrolate Dose 2 of Glycopyrrolate Dose 1 of Glycopyrronium Dose 2 of Glycopyrronium Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/21 (19.05%)   8/20 (40.00%)   11/22 (50.00%)   10/20 (50.00%)   6/21 (28.57%) 
Cardiac disorders           
Tachycardia   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Eye disorders           
Mydriasis   1/21 (4.76%)  1/20 (5.00%)  1/22 (4.55%)  0/20 (0.00%)  0/21 (0.00%) 
Ocular Hyperaemia   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Vision blurred   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Gastrointestinal disorders           
Dry Mouth   3/21 (14.29%)  4/20 (20.00%)  6/22 (27.27%)  5/20 (25.00%)  1/21 (4.76%) 
Abdominal distension   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Constipation   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Decrease Appetite   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Tongue disorder   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Toothache   0/21 (0.00%)  0/20 (0.00%)  2/22 (9.09%)  0/20 (0.00%)  0/21 (0.00%) 
General disorders           
Application Site Pain   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  5/21 (23.81%) 
Drug Interaction   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Injection Site Bruising   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Pain   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Infections and infestations           
Nasopharyngitis   0/21 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  1/20 (5.00%)  1/21 (4.76%) 
Pharyngitis streptococcal   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Upper Respiratory Tract Infection   0/21 (0.00%)  0/20 (0.00%)  2/22 (9.09%)  1/20 (5.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications           
Accidental Exposure to Product   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Excoriation   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Ligament Sprain   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders           
Dehydration   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain   1/21 (4.76%)  0/20 (0.00%)  2/22 (9.09%)  0/20 (0.00%)  0/21 (0.00%) 
Nervous system disorders           
Dysgeusia   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Headache   0/21 (0.00%)  0/20 (0.00%)  3/22 (13.64%)  1/20 (5.00%)  0/21 (0.00%) 
Paraesthesia   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Psychiatric disorders           
Panic attack   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Renal and urinary disorders           
Urinary retention   0/21 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  1/20 (5.00%)  0/21 (0.00%) 
Urinary incontinence   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Nasal dryness   0/21 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Nasal congestion   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders           
Erythema   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Hypohidrosis   0/21 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Eugene A. Bauer, MD, Chief Medical Officer
Organization: Dermira, Inc.
Phone: 650-421-7202
EMail: eugene.bauer@dermira.com
Layout table for additonal information
Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT02129660     History of Changes
Other Study ID Numbers: DRM04-HH02
First Submitted: April 30, 2014
First Posted: May 2, 2014
Results First Submitted: July 17, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018