2016885
Last Update Posted: 2021-08-25
Recruiting has ended
All Genders accepted | 18 Years + |
198 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
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.
Eligibility
Relevant conditions:
Hyperhidrosis
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov