A multi-centre, double-blind, randomised, vehicle-controlled study for a quantitative estimation of hair re-growth in male subjects with androgenetic alopecia treated over 6 month with two ethanolic PSK 3841 solutions (2.5% and 5%)
- Conditions
- Androgenetic alopecia.Skin and Connective Tissue DiseasesAndrogenetic alopecia
- Registration Number
- ISRCTN71083772
- Lead Sponsor
- ProStrakan Pharmaceuticals (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 120
1. Men aged between 18 and 50 years with an androgenetic alopecia rated as Norwood-Hamilton stage IIIa, IIIv, IV, IVa and V
2. Subjects in good health, with no relevant abnormalities in their medical history, physical examination and vital signs
3. Willingness to refrain from using any hair enhancement products or procedures for the duration of the study
1. Men whose female partner is pregnant or of childbearing potential and not using adequate efficacious contraception
2. Subjects with hair loss due to causes other than androgenetic balding
3. Subjects with scalp diseases other than androgenetic balding
4. Subjects who have had a clinically important illness within the past 6 months before the study entry, which potentially could affect hair growth/loss
5. Any pathology or abnormality of the skin in the areas to be treated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total and anagen hair numbers<br>2. Safety and tolerability
- Secondary Outcome Measures
Name Time Method 1. Investigator hair scalp assessment and patient hair growth questionnaire<br>2. Pharmacokinetics of PSK 3841 and its metabolites