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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
FOL100 lotion
Oral Finasteride
Rabin Medical Center
Petah Tikva, Israel
RECRUITINGSheba Medical Center
Ramat Gan, Israel
RECRUITINGSourasky Medical Center
Tel Aviv, Israel
RECRUITINGSafety of product application
Adverse event reporting (local and general)
Time frame: 28 weeks
Tolerability & Usability
Subject self-assessment by questionnaire
Time frame: 28 weeks
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