Androgenetic alopecia. Skin and Connective Tissue Diseases Androgenetic alopecia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total and anagen hair numbers 2. Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Investigator hair scalp assessment and patient hair growth questionnaire 2. Pharmacokinetics of PSK 3841 and its metabolites | — |
Countries
United Kingdom