Androgenetic alopecia. Skin and Connective Tissue Diseases Androgenetic alopecia
Conditions
Interventions
5% PSK 3841 solution or vehicle.
Sponsors
ProStrakan Pharmaceuticals (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For male subjects: 1. Caucasian healthy male subjects aged between 18 and 50 years old with an androgenic alopecia graded as IIIa, IIIv, IV, IVa or V according to Norwood-Hamilton classification 2. Subjects cohabiting with their female partner during all the study treatment For their female partners: 1. Healthy female subjects
Exclusion criteria
Exclusion criteria: For male subjects: 1. Mobile working activities preventing sleeping at home on a regular basis 2. Baldness due to medical illness, alopecia aerata, trichotillomania or any other form of pathologic alopecia other than androgenetic alopecia 3. Any pathology or abnormality of the skin in the areas to be treated 4. History of skin allergy 5. Regular use of medication which might interfere with the results of the study For their female partners: 1. Mobile working activities preventing sleeping at home on a regular basis 2. Pregnant or lactating female 3. Female of childbearing potential without adequate efficacious contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability based on pharmacodynamic endocrine profile (gonadotropins, steroids) on day 1, 15 and 28 of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To characterize the pharmacokinetics of PSK 3841 and its metabolites in alopecic males treated twice daily with topical applications on the scalp over a 4-week period 2. To assess whether an eventual exposure to PSK 3841 in untreated female partners occurred under real life conditions during the study | — |
Countries
France
Outcome results
None listed