Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

Inclusion Criteria:

• Written informed consent before starting any study related procedures;

• Men 18 to 40 years of age;

• Men with mild to moderate vertex male pattern hair loss according to a modifiedNorwood/Hamilton classification scale (III vertex, IV or V);

• Participants willing to have a tattoo in the target area;

• Outpatients;

• Ability to comprehend the full nature and purpose of the study, including possiblerisks and side effects;

• Ability to co-operate with the Investigator and to comply with the requirements of theentire study.

Exclusion Criteria:

• Clinically relevant abnormal skin scalp findings which could interfere with the aim ofthe study; in particular, abrasion, actinic keratosis, inflammatory disorders or anyother abnormality;

• Participants who had had hair transplant surgery or hair weaving;

• Clinically relevant abnormal laboratory values indicative of physical illness;

• Ascertained or presumptive hypersensitivity to the active principle and/orformulations' ingredients; history of anaphylaxis to drugs or allergic reactions ingeneral, which the Investigator considers may affect the outcome of the study;

• History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;

• Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,skin, haematological, endocrine or neurological diseases, that may interfere with theaim of the study;

• Suspicion of malignancy, including prostate cancer;

• History of infertility or difficulty fathering children;

• Participants who wish to conceive children during the study or whose sexual partner(s)is pregnant;

• Participants with active seborrheic dermatitis;

• History of varicocele;

• Concurrent use of systemic corticosteroids, topical corticosteroids in the baldingarea studied, anabolic steroids, or over-the-counter "hair restorers";

• Use of the following drugs with antiandrogenic properties within 6 months of studyentry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine,spironolactone or ketoconazole;

• Participants who had been treated with any of the following drugs within the pastyear: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin,systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen,phenothiazines or cytotoxic agents;

• Use of finasteride or dutasteride within previous 12 months;

• Light or laser treatment of scalp within previous 3 months;

• Participation in the evaluation of any drug for 3 months before this study, calculatedfrom the first day of the month following the last visit of the previous study;

• History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).