This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
564
Glycopyrronium Topical Wipes
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
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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Coastal Medical Research Group LLC
Mobile, Alabama, United States
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Colorado Medical Research Center, Inc
Denver, Colorado, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
Study Protocol, Inc
Boynton Beach, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
...and 38 more locations