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A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers

NCT04774874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2021-03-01

No results posted yet for this study

Summary

This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.

Conditions

Interventions

DRUG

Topical formulation

Topical administration on the scalp once daily for 16 weeks

Sponsors & Collaborators

  • proDERM GmbH

    collaborator INDUSTRY

  • Hair and Skin Institute, Charité, Berlin, Germany

    collaborator UNKNOWN

  • CentroDerm GmbH

    collaborator NETWORK

  • Follicum AB

    lead INDUSTRY

Principal Investigators

  • Ulrike Blume-Peytavi · Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2021-01-29
Completion
2021-01-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04774874 on ClinicalTrials.gov