A double blind, randomised, vehicle-controlled, safety and tolerance study of topical PSK 3841 solution at 5% administered twice daily over four weeks to healthy Caucasian males with androgenetic alopecia
- Conditions
- Androgenetic alopecia.Skin and Connective Tissue DiseasesAndrogenetic alopecia
- Registration Number
- ISRCTN49873657
- Lead Sponsor
- ProStrakan Pharmaceuticals (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability based on pharmacodynamic endocrine profile (gonadotropins, steroids) on day 1, 15 and 28 of treatment.
- Secondary Outcome Measures
Name Time Method 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<br>2. To assess whether an eventual exposure to PSK 3841 in untreated female partners occurred under real life conditions during the study