Androgeneic alopecia Skin and Connective Tissue Diseases Androgenic alopecia, unspecified
Conditions
Interventions
1. First group: 7-day treatment of the scalp skin area with a new topical finasteride formulation (0.25%) b.i.d. (every 12 hours)
2. Second group: 7-day treatment with finasteride oral formulation 1 m
Sponsors
Polichem S.A. (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Sex: male 2. Age: 18-65 year-old inclusive 3. Androgeneic 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. Body Mass Index (BMI): 18 < BMI < 30 kg/m2; 5. Vital signs: Systolic Blood Pressure (SBP) 100-139 mmHg, Diastolic Blood Pressure (DBP) 50-89 mmHg, Heart Rate (HR) 50-90 bpm, measured after 5 min of rest in the sitting position 6. Full comprehension: 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 7. Informed Consent: signed written informed consent prior to inclusion in the study
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (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 (>10 cigarettes/day) 10. Abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of finasteride after single and multiple dose administration of topical or oral finasteride formulation measured using a validated UPLC-MS/MS method. Time points: 1. Before the first drug administration 2. 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 h after the first dose 3. Before last drug administration 4. 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 h after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma levels of testosterone and dihydrotestosterone after single and multiple dose administration of topical or oral finasteride formulation determined using a validated LC-MS/MS method. Time points: 1. Before the first drug administration 2. 6, 12 and 24 h after the first dose 3. Before last drug administration 4. 6, 12, 24 and 36 h after the last dose 2. Adverse events (AEs), vital signs (BP, HR), ECG, physical examination, laboratory parameters measured at screening visit and at the end of the trial (final visit). | — |
Countries
Switzerland
Outcome results
None listed