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

Hyperhidrosis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02016885
Study type Interventional
Source Journey Medical Corporation
Contact
Status Completed
Phase Phase 2
Start date November 2013
Completion date September 2014
View Details
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