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Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis

NCT05863104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-04-04

No results posted yet for this study

Summary

The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.

Conditions

  • Primary Axillary Hyperhidrosis

Interventions

DRUG

Glycopyrronium Bromide (GPB) Cream

Application of cream to each axilla

Sponsors & Collaborators

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2024-03-06
Completion
2024-03-06

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 NCT05863104 on ClinicalTrials.gov