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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.

NCT03658616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2023-04-28

No results posted yet for this study

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

DRUG

WO3970

Application of cream to each axilla

DRUG

Placebo (WO3988)

Application of cream to each axilla

Sponsors & Collaborators

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

    lead INDUSTRY

Principal Investigators

  • Prof. Rolf-Markus Szeimies, MD · Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2021-11-02
Completion
2022-02-02

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658616 on ClinicalTrials.gov