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Trial record 38 of 166 for:    "Sweat Gland Disease"

Long-term Safety Study of Glycopyrronium in Subjects With Primary 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: NCT02553798
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : September 25, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperhidrosis
Intervention Drug: Glycopyrronium Topical Wipes
Enrollment 564
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glycopyrronium
Hide Arm/Group Description Glycopyrronium Topical Wipes
Period Title: Overall Study
Started 564
Completed 226
Not Completed 338
Arm/Group Title Glycopyrronium
Hide Arm/Group Description Glycopyrronium Topical Wipes
Overall Number of Baseline Participants 564
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants
<=18 years
60
  10.6%
Between 18 and 65 years
499
  88.5%
>=65 years
5
   0.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants
Female
309
  54.8%
Male
255
  45.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants
Hispanic or Latino
97
  17.2%
Not Hispanic or Latino
467
  82.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants
American Indian or Alaska Native
2
   0.4%
Asian
3
   0.5%
Native Hawaiian or Other Pacific Islander
1
   0.2%
Black or African American
64
  11.3%
White
470
  83.3%
More than one race
24
   4.3%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
Hide 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.
Time Frame Day 1 - Week 44
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Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium
Hide Arm/Group Description:
Glycopyrronium Topical Wipes
Overall Number of Participants Analyzed 550
Measure Type: Number
Unit of Measure: Adverse Events and Local Skin Reactions
Mild AEs 148
Moderate AEs 153
Severe AEs 28
Mild LSRs 120
Moderate LSRs 44
Severe LSRs 15
2.Other Pre-specified 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 Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium
Hide Arm/Group Description:
Glycopyrronium Topical Wipes
Overall Number of Participants Analyzed 430
Mean (Standard Deviation)
Unit of Measure: mg/5 min
-95.68  (140.806)
3.Other Pre-specified Outcome
Title Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
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.
Time Frame Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium
Hide Arm/Group Description:
Glycopyrronium Topical Wipes
Overall Number of Participants Analyzed 437
Measure Type: Number
Unit of Measure: participants
3 - point improvement 72
2 - point improvement 204
1 - point improvement 135
no improvement 26
4.Other Pre-specified Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
Hide Description The Dermatology Life Quality Index 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 (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Participant
Arm/Group Title Glycopyrronium
Hide Arm/Group Description:
Glycopyrronium Topical Wipes
Overall Number of Participants Analyzed 406
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-8.7  (6.24)
Time Frame up to 45 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 Glycopyrronium
Hide Arm/Group Description

Glycopyrronium Topical Wipes

Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes

All-Cause Mortality
Glycopyrronium
Affected / at Risk (%)
Total   0/550 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glycopyrronium
Affected / at Risk (%)
Total   7/550 (1.27%) 
Eye disorders   
Mydriasis   1/550 (0.18%) 
General disorders   
Chest pain   1/550 (0.18%) 
Infections and infestations   
Diverticulitis   1/550 (0.18%) 
Infectious colitis   1/550 (0.18%) 
Injury, poisoning and procedural complications   
Concussion   1/550 (0.18%) 
Psychiatric disorders   
Affective disorder   1/550 (0.18%) 
Suicide attempt   1/550 (0.18%) 
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
Affected / at Risk (%)
Total   178/550 (32.36%) 
Eye disorders   
Vision blurred   37/550 (6.73%) 
Mydriasis   28/550 (5.09%) 
Gastrointestinal disorders   
Dry Mouth   93/550 (16.91%) 
General disorders   
Application Site Pain   35/550 (6.36%) 
Infections and infestations   
Nasopharyngitis   32/550 (5.82%) 
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: NCT02553798     History of Changes
Other Study ID Numbers: DRM04-HH06
First Submitted: September 15, 2015
First Posted: September 18, 2015
Results First Submitted: July 20, 2018
Results First Posted: September 25, 2018
Last Update Posted: October 24, 2018