Study of two different formulations of finasteride in male volunteers with androgenetic alopecia

INTERVENTION: First and second group: 7‐day treatment of the scalp skin area with a new topical finasteride formulation (0.25%) o.d. or b.i.d. (every 12 hours), the third group of volunteers will be treated with finasteride oral formulation 1 mg o.d. Two weeks before starting the treatment and after last treatment dose, two scalp biopsies will be taken. CONDITION: Androgenetic alopecia ; Skin and Connective Tissue Diseases ; Androgenic alopecia PRIMARY OUTCOME: Serum and scalp concentration of testosterone and dihydrotestosterone before and after multiple dose administration of topical or oral finasteride formulation SECONDARY OUTCOME: 1. Adverse events; 2. Vital signs (blood pressure, heart rate); 3. Electrocardiogram ; 4. Physical examination; 5. Laboratory parameters INCLUSION CRITERIA: 1. Sex ‐ male 2. Age: 18‐65 year olds inclusive 3. Androgenetic alopecia: recession of the frontal hairline and hair loss in the vertex or crown or loss of hair over the frontal and vertex scalp regions, corresponding to at least stage 2 of the Hamilton‐Norwood scale 4. BMI: 18, TBMI, T30 kg/m2 5. Vital signs: SBP 100‐139 mmHg, DBP 50‐89 mmHg, HR 50‐90 bpm, measured after 5 min of rest in the sitting position 6. Full comprehension: 6.1. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects 6.2. Ability to co‐operate with the Investigator and to comply with the requirements of the entire study 7. Informed consent: signed written informed consent prior to inclusion in the study