Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:00 AM
Study NCT ID:
NCT05611593
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia
Sponsor:
Follicle Pharma Ltd
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: