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Trial record 12 of 185 for:    GLYCOPYRROLATE

A Dose-Ranging Study of the Effect of Glycopyrrolate 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: NCT02016885
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : September 13, 2018
Last Update Posted : September 13, 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: glycopyrrolate, 1.0%
Drug: glycopyrrolate, 2.0%
Drug: glycopyrrolate, 3.0%
Drug: glycopyrrolate, 4.0%
Other: Vehicle
Enrollment 198
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description glycopyrrolate Topical Wipes, 1.0% glycopyrrolate Topical Wipes, 2.0% glycopyrrolate Topical Wipes, 3.0% glycopyrrolate Topical Wipes, 4.0% Vehicle Topical Wipes
Period Title: Overall Study
Started 38 40 40 40 40
Completed 34 36 39 30 39
Not Completed 4 4 1 10 1
Arm/Group Title Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle Total
Hide Arm/Group Description glycopyrrolate Topical Wipes, 1.0% glycopyrrolate Topical Wipes, 2.0% glycopyrrolate Topical Wipes, 3.0% glycopyrrolate Topical Wipes, 4.0% Vehicle Topical Wipes Total of all reporting groups
Overall Number of Baseline Participants 38 40 40 40 40 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 40 participants 40 participants 40 participants 198 participants
<=18 years
2
   5.3%
2
   5.0%
0
   0.0%
1
   2.5%
0
   0.0%
5
   2.5%
Between 18 and 65 years
36
  94.7%
36
  90.0%
40
 100.0%
39
  97.5%
38
  95.0%
189
  95.5%
>=65 years
0
   0.0%
2
   5.0%
0
   0.0%
0
   0.0%
2
   5.0%
4
   2.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 40 participants 40 participants 40 participants 198 participants
Female
16
  42.1%
21
  52.5%
17
  42.5%
23
  57.5%
21
  52.5%
98
  49.5%
Male
22
  57.9%
19
  47.5%
23
  57.5%
17
  42.5%
19
  47.5%
100
  50.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 40 participants 40 participants 40 participants 198 participants
Hispanic or Latino
4
  10.5%
8
  20.0%
3
   7.5%
2
   5.0%
4
  10.0%
21
  10.6%
Not Hispanic or Latino
34
  89.5%
32
  80.0%
37
  92.5%
38
  95.0%
36
  90.0%
177
  89.4%
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 38 participants 40 participants 40 participants 40 participants 40 participants 198 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
0
   0.0%
1
   2.5%
1
   2.5%
1
   2.5%
0
   0.0%
3
   1.5%
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
4
  10.5%
4
  10.0%
2
   5.0%
3
   7.5%
3
   7.5%
16
   8.1%
White
34
  89.5%
34
  85.0%
34
  85.0%
30
  75.0%
37
  92.5%
169
  85.4%
More than one race
0
   0.0%
1
   2.5%
2
   5.0%
6
  15.0%
0
   0.0%
9
   4.5%
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
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
14
  36.8%
20
  50.0%
21
  52.5%
18
  45.0%
9
  22.5%
2.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 Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: mg/5 min
-56.63  (75.02) -67.17  (61.26) -91.39  (71.27) -88.40  (103.85) -55.80  (80.65)
3.Secondary 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 Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
27
  71.1%
30
  75.0%
35
  87.5%
25
  62.5%
28
  70.0%
4.Secondary 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 Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: mg/5 min
-32.08  (68.55) -51.36  (52.30) -72.23  (64.21) -57.15  (165.66) -55.14  (56.92)
5.Secondary 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 Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
24
  63.2%
27
  67.5%
29
  72.5%
23
  57.5%
25
  62.5%
6.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
Hide Description The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Time Frame Baseline - Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description:
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Overall Number of Participants Analyzed 38 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-6.2  (6.0) -6.6  (4.9) -7.0  (5.1) -5.9  (4.7) -3.8  (4.6)
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 Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Hide Arm/Group Description glycopyrrolate Topical Wipes, 1.0% glycopyrrolate Topical Wipes, 2.0% glycopyrrolate Topical Wipes, 3.0% glycopyrrolate Topical Wipes, 4.0% Vehicle Topical Wipes
All-Cause Mortality
Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)      0/39 (0.00%)      0/40 (0.00%)      0/40 (0.00%)      0/39 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/39 (0.00%)      1/40 (2.50%)      0/40 (0.00%)      0/39 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant melanoma in situ  [1]  0/36 (0.00%)  0 0/39 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Nevus of the left upper abdomen
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glycopyrrolate, 1.0% Glycopyrrolate, 2.0% Glycopyrrolate, 3.0% Glycopyrrolate, 4.0% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/36 (25.00%)      17/39 (43.59%)      18/40 (45.00%)      23/40 (57.50%)      10/39 (25.64%)    
Eye disorders           
Mydriasis  [1]  2/36 (5.56%)  1/39 (2.56%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Vision blurred   0/36 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  4/40 (10.00%)  0/39 (0.00%) 
Gastrointestinal disorders           
Constipation   1/36 (2.78%)  1/39 (2.56%)  1/40 (2.50%)  2/40 (5.00%)  0/39 (0.00%) 
Dry Mouth   5/36 (13.89%)  9/39 (23.08%)  14/40 (35.00%)  15/40 (37.50%)  5/39 (12.82%) 
Infections and infestations           
Nasopharyngitis   0/36 (0.00%)  4/39 (10.26%)  2/40 (5.00%)  2/40 (5.00%)  2/39 (5.13%) 
Sinusitis   0/36 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  2/39 (5.13%) 
Upper respiratory tract infection   2/36 (5.56%)  1/39 (2.56%)  3/40 (7.50%)  1/40 (2.50%)  3/39 (7.69%) 
Application Site Folliculitis   0/36 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  1/40 (2.50%)  0/39 (0.00%) 
Renal and urinary disorders           
Dysuria   0/36 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  3/40 (7.50%)  0/39 (0.00%) 
Urinary retention   0/36 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  3/40 (7.50%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Epistaxis   0/36 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  2/40 (5.00%)  0/39 (0.00%) 
Nasal dryness   0/36 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  2/40 (5.00%)  0/39 (0.00%) 
Oropharyngeal pain   0/36 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  2/40 (5.00%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders           
Dry skin   0/36 (0.00%)  2/39 (5.13%)  3/40 (7.50%)  2/40 (5.00%)  0/39 (0.00%) 
Hyperhidrosis   0/36 (0.00%)  2/39 (5.13%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Hypohidrosis   0/36 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  2/40 (5.00%)  0/39 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Mydriasis
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: NCT02016885     History of Changes
Other Study ID Numbers: DRM04-HH01
First Submitted: December 16, 2013
First Posted: December 20, 2013
Results First Submitted: July 17, 2018
Results First Posted: September 13, 2018
Last Update Posted: September 13, 2018