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Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis

NCT03037788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-04-08

No results posted yet for this study

Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.

Conditions

  • Primary Axillary Hyperhidrosis

Interventions

DRUG

WO3979

Application of cream to each axilla

DRUG

WO3970

Application of cream to each axilla

DRUG

WO3992

Application of cream to each axilla

DRUG

Placebo (WO3988)

Application of cream to each axilla

Sponsors & Collaborators

  • Nuvisan GmbH

    collaborator UNKNOWN

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Charles River Biopharmaceutical Services GmbH

    collaborator UNKNOWN

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

    lead INDUSTRY

Principal Investigators

  • Prof. Christoph Abels, MD, PhD · Dr. August Wolff GmbH & Co. KG Arzneimittel

  • Horst Jürgen Heuer, MD · Nuvisan GmbH

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
2016-11-30
Primary Completion
2017-06-30
Completion
2017-07-31

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 NCT03037788 on ClinicalTrials.gov