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

Launched by FOLLICLE PHARMA LTD · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial, called CSP-001-FOL1, is looking at a new lotion called FOL100 that is applied to the scalp to treat male pattern hair loss, also known as androgenetic alopecia. The main goals are to see if this lotion is safe to use and whether it works better than a common oral medication called Finasteride. Men between the ages of 18 and 45 with mild to moderate hair loss on the top of their heads may be eligible to participate, as long as they agree to maintain their normal hair care routine during the study and don’t have any significant scalp issues or health conditions that could interfere.

Participants in the trial will choose whether they want to use the FOL100 lotion or take the oral Finasteride. Throughout the study, researchers will closely monitor participants for any side effects and evaluate how well the treatment is working. It's important to note that anyone interested in joining should be willing to follow specific guidelines, including maintaining their haircut and hair color for the study's duration. If you meet the criteria and are interested, this trial may provide an opportunity to explore a new treatment for hair loss.

Gender

MALE

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.