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

Launched by POLICHEM S.A. · Dec 23, 2016

Keywords

ClinConnect Summary

No description provided

Gender

MALE

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).