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

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Drug: FOL100; Drug: Propecia 1Mg Tablet

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Solli Brawer; Phone Number: +972747366444; Email: info@folliclepharma.com
• Study Contact Backup: Name: Offer Fabian; Phone Number: +972747366444; Email: info@folliclepharma.com

Study Locations

• Israel
  • Petah tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Helena Martinez, MD
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Anna Lyakhovitsky, MD
  • Tel Aviv, Israel
    • Recruiting
    • Sourasky Medical Center
    • Contact: Amir Koren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent will be signed by the subject before starting any study related procedures.
2. Male subject between the ages of 18 to 45 years old.
3. Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex to V, according to the modified Norwood/Hamilton Scale.
4. Subject must be willing to maintain normal shampooing habits and products during the study.
5. Fitzpatrick skin phototype classification of I-IV.
6. Subjects will agree to maintain the same haircut and color throughout the study, with no significant changes that will interfere with study objectives, as determined by the investigator.
7. Ability to understand and cooperate with the investigator and to comply with the requirements of the study protocol.

Exclusion Criteria:

1. Clinically significant abnormal skin findings on the scalp, which in the opinion of the investigator, could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders, or any other abnormality.
2. Hair transplant surgery or hair weaving.
3. Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening.
4. Ascertained or presumptive hypersensitivity to the active principle and/or any of the formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the investigator may affect subject safety or the outcome of the study.
5. History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment.
6. Clinically significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases, which in the opinion of the investigator may affect subject safety or the outcome of the study.
7. Suspicion of malignancy, including prostate cancer.
8. Subject whose sexual partner(s) is pregnant or plan to become pregnant.
9. Concurrent use of systemic corticosteroids, topical corticosteroids in the area treated in the study, anabolic steroids, or over the counter "hair restorers".
10. Use of any of the following products 1 year for systemic use and 6 months for topical use: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine ,benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents.
11. Use of oral finasteride or dutasteride, within 18 months prior to enrollment and 6 months prior to enrollment for any topical medication that is considered to affect hair growth.
12. Use of a therapeutic shampoo for hair loss within 1 month prior to enrollment.
13. Light or laser treatment of scalp within 3 months prior to enrollment.
14. Unwilling to undergo a superficial ink marking on the scalp vertex during V0.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOL100; Subjects will apply FOL100 lotion topically in the defined treatment area.	Drug: FOL100; FOL100 lotion
Active Comparator: Propecia 1mg (oral Finasteride); Participants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d)	Drug: Propecia 1Mg Tablet; Oral Finasteride; Other Names: Oral Finasteride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of product application	Adverse event reporting (local and general)	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability & Usability	Subject self-assessment by questionnaire	28 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hair count	Change in total hair count, vellus and non-vellus hair count per cm^2 as assessed by Phototrichogram	28 weeks
Change in total hair density	Change in total hair density per cm^2 as assessed by Phototrichogram	28 weeks
Change in hair thickness	Change in cumulative diameter and hair thickness per cm^2 as assessed by Phototrichogram	28 weeks
Exploratory Endpoint: Efficacy - self-assess	Subject self-assessment by questionnaire	28 weeks

Collaborators and Investigators

• Sponsor: Follicle Pharma Ltd
• Investigators: Study Director: Solli Brawer, Follicle Pharma Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: CSP-001-FOL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No