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

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ClinicalTrials.gov Identifier: NCT05611593
Recruitment Status : Recruiting
First Posted : November 10, 2022
Last Update Posted : November 10, 2022
Information provided by (Responsible Party):
Follicle Pharma Ltd

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.

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Drug: FOL100 Drug: Propecia 1Mg Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Finasteride

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 Name: Oral Finasteride

Primary Outcome Measures :
  1. Safety [ Time Frame: 28 weeks ]
    Adverse event reporting (local and general)

Secondary Outcome Measures :
  1. Tolerability & Usability [ Time Frame: 28 weeks ]
    Subject self-assessment by questionnaire

Other Outcome Measures:
  1. Change in hair count [ Time Frame: 28 weeks ]
    Change in total hair count, vellus and non-vellus hair count per cm^2 as assessed by Phototrichogram

  2. Change in total hair density [ Time Frame: 28 weeks ]
    Change in total hair density per cm^2 as assessed by Phototrichogram

  3. Change in hair thickness [ Time Frame: 28 weeks ]
    Change in cumulative diameter and hair thickness per cm^2 as assessed by Phototrichogram

  4. Exploratory Endpoint: Efficacy - self-assess [ Time Frame: 28 weeks ]
    Subject self-assessment by questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 40 years old.
  3. Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex and IV, 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 in the past year that may affect hair growth:

    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 12 months prior to enrollment for any topical medication that is considered to affect hair growth.
  12. Use of a therapeutic shampoo administered by a physician with prescription 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05611593

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Contact: Solli Brawer +972747366444 info@folliclepharma.com
Contact: Offer Fabian +972747366444 info@folliclepharma.com

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Rabin Medical Center Recruiting
Petah tikva, Israel
Contact: Helena Martinez, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Anna Lyakhovitsky, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Amir Koren         
Sponsors and Collaborators
Follicle Pharma Ltd
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Study Director: Solli Brawer Follicle Pharma Ltd
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Responsible Party: Follicle Pharma Ltd
ClinicalTrials.gov Identifier: NCT05611593    
Other Study ID Numbers: CSP-001-FOL1
First Posted: November 10, 2022    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents