The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study. Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production. Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs. PK samples will be taken from 20 to 30 subjects participating in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
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
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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: Baseline - Week 4
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Time frame: Baseline - Week 4
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Time frame: Baseline - Week 6
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Time frame: Baseline - Week 6
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Gary M. Petrus, MD, PA
Little Rock, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Center For Dermatology Clinical Research
Fremont, California, United States
Florida Academic Dermatology Center
Miami, Florida, United States
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
...and 11 more locations
Time frame: Baseline - Week 4