Androgenetic alopecia Skin and Connective Tissue Diseases Androgenic alopecia
Conditions
Interventions
Thirty-two male volunteers will be randomly divided into four different cohorts (A, B, C and D). Each cohort will be composed of 8 subjects
within each cohort 6 subjects will be randomly allocated to receive a 7-day treatment of the scalp skin area with P-3074 (a new topical finasteride 0.25% formulation) and 2 subjects will receive place
Sponsors
Polichem SA (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: To be enrolled in this study, subjects must fulfil all of these criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: males, 18-65 years old 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. Body mass index: 18.5-30 kg/m2 inclusive 5. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at 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
Exclusion criteria
Exclusion criteria: Subjects meeting any of these criteria will not be enrolled in the study: 1. ECG: clinically relevant abnormalities at ECG (12 leads) 2. Skin of the scalp: skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp 3. Physical findings: clinically relevant abnormal physical findings 4. Laboratory analysis: clinically relevant abnormal laboratory values indicative of physical illness 5. 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 6. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study 7. Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study (the anaesthetic used for the biopsies will be allowed; paracetamol and oral peri-operative antibiotic prophylaxis will be administered as needed) 8. Investigative drug studies: participation in the evaluation of any drug for 3 months starting from the first day of the month following the last visit in a previous study 9. Blood donations: blood donations for 3 months before this study 10. Drug, alcohol, caffeine, tobacco: 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) 11. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits within the past 4 weeks 12. Alcohol test: positive alcohol breath test before starting P-3074 administration 13. Drug abuse: positive abuse drug test at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scalp and serum concentrations of dihydrotestosterone (DHT) at baseline and 6 ± 2 h after the last P-3074 or placebo dose (day 7). Two biopsies at each sampling time (baseline and 6 ± 2 h after last dose) will be taken. DHT in scalp and serum samples will be determined using validated analytical methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentrations of finasteride at baseline and 6 ± 2 h after the last P-3074 or placebo dose (day 7) will be determined using validated analytical methods. 2. Scalp and serum concentrations of testosterone at baseline and 6 ± 2 h after the last P-3074 or placebo dose (day 7) will be determined using validated analytical methods. 3. Amount of finasteride per cm2 of adhesive tape strips - unabsorbed finasteride (2 tape strips per each time point will be applied and collected) at 12, 14, 16 and 16.5 h after the last dose of P-3074 or placebo (only for cohort D). The samples at 16.5 h will be collected after the shower. 4. Amount of finasteride per cm2 of adhesive tape strips - stratum corneum (20 tape strips per each time point will be applied and collected) at 12, 14 and 16 h after the last dose of P-3074 or placebo (only for cohort D). 5. Safety and tolerability: based on adverse events, physical examinations, vital signs, ECG and routine haematology, blood chemistry and urinalysis laboratory tests. | — |
Countries
Switzerland
Outcome results
None listed