The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Pre-saturated 100% polypropylene, nonwoven, fabric cloth
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, United States
International Dermatology Research, Inc.
Miami, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].
Time frame: Baseline, Week 2
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
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 (better), 2, 3, 4 (worse)
Time frame: Baseline, Week 2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Time frame: Baseline, Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Time frame: Baseline, Week 2
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Time frame: Baseline, Week 2
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Saint Louis University Dermatology
St Louis, Missouri, United States
Innovative Dermatology/ ACRC Trials
Plano, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States