The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.
This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis. Safety will be assessed through lab tests, ECG, physical exams and vital signs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
344
Topical wipes containing glycopyrronium
Vehicle (placebo) topical wipes
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Time frame: From Baseline to Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
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: From Baseline to Week 4
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time frame: From Baseline to Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Time frame: Baseline - Week 4
Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Therapeutics Clinical Research
San Diego, California, 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
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States
Research Institute of the Southeast
West Palm Beach, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Prairie Health and Wellness
Wichita, Kansas, United States
...and 21 more locations
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. 1 (Best), 2, 3, 4 (Worst)
Time frame: From Baseline to Week 4
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time frame: From Baseline to Week 4