NCT04774874

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

A Randomized, Double-blind, Vehicle-controlled, Dose-finding Multi-center, Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers With Androgenetic Alopecia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Follicum AB · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The trial will be performed at three centers in Germany. The aim of the trial is to determine the most efficacious dose of FOL-005 topical formulation based on efficacy dose trends. It is planned to randomize 220 subjects (with a ratio 1:1:1:1 FOL-005 0.1%; FOL-005 0.5%; FOL-005 1.5%; vehicle). The trial consists of a screening period of up to three weeks and a treatment period of 16 weeks. Eligible subjects will be randomized at Baseline (Day 1) and will apply the investigational products themselves at home once daily for 16 weeks. Subjects will return to the sites bi- weekly for check of compliance and assessment of local tolerability. At Day1, Day 84 and Day 112 subjects will be evaluated for hair growth parameters by TrichoLAB imaging. The end of the clinical trial for each individual subject is defined as the Final Visit at Day 112. In case of premature termination of a randomized subject an Early Termination (ET) visit should be performed.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Topical formulation	Topical administration on the scalp once daily for 16 weeks

Timeline

• Start date: 2020-06-24
• Primary completion: 2021-01-29
• Completion: 2021-01-29
• First posted: 2021-03-01
• Last updated: 2021-03-01

Locations

1 site across 1 country: Germany