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
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: Glycopyrronium Topical Wipes||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||564 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Glycopyrronium Topical Wipes
Drug: Glycopyrronium Topical Wipes
Glycopyrronium Topical Wipes
Other Name: DRM04
- Long-term Safety Assessed Through Adverse Events and Local Skin Reactions [ Time Frame: Day 1 - Week 44 ]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.
- Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]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.
- Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]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.
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553798
Show 48 Study Locations
|Study Director:||Lynne Deans, MT||Dermira, Inc.|