Evaluating a new lotion for male pattern baldness

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

This study is testing a new lotion for hair loss in men to see if it works as well as a common pill and if it’s safe to use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Male
• Sponsor: Follicle Pharma Ltd (Industry-sponsored)
• Locations: 3 sites (Petah tikva and 2 other locations)
• Trial ID: NCT05611593 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety, tolerability, and usability of a new topical lotion, FOL100, compared to the oral medication Finasteride 1mg in male subjects experiencing androgenetic alopecia. Participants will choose their preferred treatment arm, and the study will measure safety and efficacy through various endpoints, including hair count and density assessments. The study aims to provide insights into the effectiveness of FOL100 while ensuring it does not cause adverse effects.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 to 45 with mild to moderate vertex male-pattern hair loss.

Not a fit: Patients with significant scalp skin abnormalities or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safer topical alternative for treating male pattern baldness.

How similar studies have performed: Other studies have shown promise in topical treatments for hair loss, but the specific formulation of FOL100 is novel.

Eligibility criteria

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.

Where this trial is running

Petah tikva and 2 other locations

• Rabin Medical Center — Petah tikva, Israel (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)
• Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Solli Brawer

Conditions Androgenic Alopecia