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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent will be signed by the subject before starting any studyrelated procedures.
- Male subject between the ages of 18 to 45 years old.
- Male subject with mild to moderate vertex male-pattern hair loss, classified as gradeIII vertex to V, according to the modified Norwood/Hamilton Scale.
- Subject must be willing to maintain normal shampooing habits and products during thestudy.
- Fitzpatrick skin phototype classification of I-IV.
- 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.
- Ability to understand and cooperate with the investigator and to comply with therequirements of the study protocol.
Exclusion
Exclusion Criteria:
- 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.
- Hair transplant surgery or hair weaving.
- Clinically significant and active physical illness that could interfere with studyobjectives or may risk patient safety as determined by the Investigator duringscreening.
- 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.
- History of local infections of the skin or subcutaneous tissues of the head within 3months prior to study enrollment.
- 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.
- 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 areatreated in the study, anabolic steroids, or over the counter "hair restorers".
- 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.
- 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.
- Use of a therapeutic shampoo for hair loss 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.
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
Connect with a study center
Rabin Medical Center
Petah tikva,
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan,
IsraelActive - Recruiting
Sourasky Medical Center
Tel Aviv,
IsraelActive - Recruiting
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