NCT02129660

Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Journey Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	Dose 1 of glycopyrrolate, 2.0% QD	Dose 1 of glycopyrrolate Topical Wipes
DRUG	Dose 2 of glycopyrrolate, 3.0% QD	Dose 2 of glycopyrrolate Topical Wipes
DRUG	Dose 1 of glycopyrronium, 2.5% QD	Dose 1 of glycopyrronium Topical Wipes
DRUG	Dose 2 of glycopyrronium, 3.75% QD	Dose 2 of glycopyrronium Topical Wipes
OTHER	Vehicle	Vehicle Topical Wipes

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-05-02
• Last updated: 2025-09-17
• Results posted: 2018-09-04

Locations

15 sites across 2 countries: United States, Canada