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

Last updated: March 6, 2024
Sponsor: Follicle Pharma Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Male Pattern Baldness

Hair Loss

Alopecia

Treatment

Propecia 1Mg Tablet

FOL100

Clinical Study ID

NCT05611593
CSP-001-FOL1
  • Ages 18-40
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent will be signed by the subject before starting any studyrelated 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 gradeIII vertex to V, according to the modified Norwood/Hamilton Scale.
  4. Subject must be willing to maintain normal shampooing habits and products during thestudy.
  5. Fitzpatrick skin phototype classification of I-IV.
  6. Subjects will agree to maintain the same haircut and color throughout the study, withno significant changes that will interfere with study objectives, as determined by theinvestigator.
  7. Ability to understand and cooperate with the investigator and to comply with therequirements of the study protocol.

Exclusion

Exclusion Criteria:

  1. Clinically significant abnormal skin findings on the scalp, which in the opinion ofthe 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 studyobjectives or may risk patient safety as determined by the Investigator duringscreening.
  4. Ascertained or presumptive hypersensitivity to the active principle and/or any of theformulation ingredients; history of anaphylaxis to drugs or allergic reactions ingeneral, which in the opinion of the investigator may affect subject safety or theoutcome of the study.
  5. History of local infections of the skin or subcutaneous tissues of the head within 3months prior to study enrollment.
  6. Clinically significant history of renal, hepatic, gastrointestinal, cardiovascular,respiratory, skin, hematological, endocrine, or neurological diseases, which in theopinion 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 areatreated 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 topicaluse: 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 6months prior to enrollment for any topical medication that is considered to affecthair 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 Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Propecia 1Mg Tablet
Phase: 1
Study Start date:
October 20, 2022
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Rabin Medical Center

    Petah tikva,
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

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