NCT02016885

A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Journey Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Detailed description

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.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	glycopyrrolate, 1.0%	glycopyrrolate Topical Wipes, 1.0%
DRUG	glycopyrrolate, 2.0%	glycopyrrolate Topical Wipes, 2.0%
DRUG	glycopyrrolate, 3.0%	glycopyrrolate Topical Wipes, 3.0%
DRUG	glycopyrrolate, 4.0%	glycopyrrolate Topical Wipes, 4.0%
OTHER	Vehicle	Vehicle Topical Wipes

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-12-20
• Last updated: 2021-08-25
• Results posted: 2018-09-13

Locations

21 sites across 1 country: United States