NCT03658616

Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.

Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.

Conditions

• Primary Axillary Hyperhidrosis

Interventions

Type	Name	Description
DRUG	WO3970	Application of cream to each axilla
DRUG	Placebo (WO3988)	Application of cream to each axilla

Timeline

• Start date: 2018-09-18
• Primary completion: 2021-11-02
• Completion: 2022-02-02
• First posted: 2018-09-05
• Last updated: 2023-04-28

Locations

1 site across 1 country: Germany