The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.
This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms. Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS). Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs. PK blood samples will be taken study subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium Topical Wipes
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Center For Dermatology Clinical Research
Fremont, California, 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/ET
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Time frame: Baseline - Week 4
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Time frame: Baseline - Week 6
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
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Time frame: Baseline - Week 6
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time frame: Baseline - Week 4
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
Time frame: Baseline - Week 6
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Dose 2 of glycopyrronium Topical Wipes
Vehicle Topical Wipes
Olympian Clinical Research
Tampa, Florida, United States
Kenneth R. Beer MD
West Palm Beach, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Haber Dermatology and Cosmetic Surgery
Beachwood, Ohio, United States
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, United States
DermResearch, Inc
Austin, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
...and 5 more locations