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
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|Condition or disease||Intervention/treatment||Phase|
|Androgenic Alopecia||Drug: FOL100 Drug: Propecia 1Mg Tablet||Phase 1|
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.
Safety-AE(s) & SAE(s) incidence rate. Secondary Endpoint: Tolerability & usability collecting information on safety, tolerability & usability.
Exploratory Endpoint: Efficacy
- Mean change in total, vellus and non-vellus hair count, total hair density, cumulative hair diameter and mean hair thickness in the target region.
- Global photographic assessments.
- Subject self-assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Group Assignment|
|Masking:||None (Open Label)|
|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|
Subjects will apply FOL100 lotion topically in the defined treatment area.
Active Comparator: Propecia 1mg (oral Finasteride)
Participants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d)
Drug: Propecia 1Mg Tablet
Other Name: Oral Finasteride
- Safety [ Time Frame: 28 weeks ]Adverse event reporting (local and general)
- Tolerability & Usability [ Time Frame: 28 weeks ]Subject self-assessment by questionnaire
- 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
- Change in total hair density [ Time Frame: 28 weeks ]Change in total hair density per cm^2 as assessed by Phototrichogram
- Change in hair thickness [ Time Frame: 28 weeks ]Change in cumulative diameter and hair thickness per cm^2 as assessed by Phototrichogram
- Exploratory Endpoint: Efficacy - self-assess [ Time Frame: 28 weeks ]Subject self-assessment by questionnaire
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Written informed consent will be signed by the subject before starting any study related procedures.
- Male subject between the ages of 18 to 40 years old.
- 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.
- Subject must be willing to maintain normal shampooing habits and products during the study.
- Fitzpatrick skin phototype classification of I-IV.
- 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.
- Ability to understand and cooperate with the investigator and to comply with the requirements of the study protocol.
- 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.
- Hair transplant surgery or hair weaving.
- Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening.
- 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.
- History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment.
- 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.
- Suspicion of malignancy, including prostate cancer.
- Subject whose sexual partner(s) is pregnant or plan to become pregnant.
- Concurrent use of systemic corticosteroids, topical corticosteroids in the area treated in the study, anabolic steroids, or over the counter "hair restorers".
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.
- 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.
- Use of a therapeutic shampoo administered by a physician with prescription within 1 month prior to enrollment.
- Light or laser treatment of scalp within 3 months prior to enrollment.
- Unwilling to undergo a superficial ink marking on the scalp vertex during V0.
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
|Contact: Solli Braweremail@example.com|
|Contact: Offer Fabianfirstname.lastname@example.org|
|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|
|Study Director:||Solli Brawer||Follicle Pharma Ltd|
|Responsible Party:||Follicle Pharma Ltd|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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