Androgenetic alopecia Skin and Connective Tissue Diseases Androgenic alopecia
Conditions
Interventions
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 fi
Sponsors
Polichem S.A. (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. ECG (12-leads) (supine position): clinically relevant abnormalities 2. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study; in particular, skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp 3. Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness 4. Allergy: 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 5. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study 6. Medications: medications, including over the counter (OTC) drugs, for 2 weeks before the start of the study 7. Investigative drug trials: 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 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day], caffeine (>5 cups coffee/tea/day) or tobacco abuse (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum and scalp concentration of testosterone and dihydrotestosterone before and after multiple dose administration of topical or oral finasteride formulation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events 2. Vital signs (blood pressure, heart rate) 3. Electrocardiogram 4. Physical examination 5. Laboratory parameters | — |
Countries
Switzerland
Outcome results
None listed