Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Condition: Alopecia, Androgenetic
MeSH terms: Alopecia; Alopecia Areata
Intervention: P-3074; Finasteride; P-3074 Vehicle; Finasteride Placebo
Intervention MeSH terms: Finasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 458.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in
      participants with androgenetic alopecia.
    

Eligibility criteria:

        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 modified
             Norwood/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 possible
             risks and side effects;

          -  Ability to co-operate with the Investigator and to comply with the requirements of the
             entire study.

        Exclusion Criteria:

          -  Clinically relevant abnormal skin scalp findings which could interfere with the aim of
             the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any
             other 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/or
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in
             general, 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 the
             aim 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 balding
             area studied, anabolic steroids, or over-the-counter "hair restorers";

          -  Use of the following drugs with antiandrogenic properties within 6 months of study
             entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine,
             spironolactone or ketoconazole;

          -  Participants who had been treated with any of the following drugs within the past
             year: 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, calculated
             from 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).