NCT05611593

Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia

A Phase-I, Open Label, Multi-Centre Clinical Study to Assess the Safety, Tolerability and Usability of FOL100 Lotion in Comparison to Oral Finasteride, for the Treatment of Androgenetic Alopecia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Follicle Pharma Ltd · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events. It is also aimed at indicating effectiveness as compared with oral Finasteride 1mg. In this non-blinded study, each patient will choose his preferred arm (oral finasteride or FOL100 location). During the study, safety and efficacy will be measured as well as usability.

Detailed description

The proposed clinical study aims to test the safety, tolerability and usability of FOL100 compared to the commercially available Finasteride 1mg Propecia in male subjects suffering from AA. Study endpoints: Primary Endpoint: Safety-AE(s) \& SAE(s) incidence rate. Secondary Endpoint: Tolerability \& usability collecting information on safety, tolerability \& usability. Exploratory Endpoint: Efficacy 1. Mean change in total, vellus and non-vellus hair count, total hair density, cumulative hair diameter and mean hair thickness in the target region. 2. Global photographic assessments. 3. Subject self-assessment.

Conditions

• Androgenic Alopecia

Interventions

Type	Name	Description
DRUG	FOL100	FOL100 lotion
DRUG	Propecia 1Mg Tablet	Oral Finasteride

Timeline

• Start date: 2022-10-20
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2022-11-10
• Last updated: 2024-03-07

Locations

3 sites across 1 country: Israel