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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%)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71083772
Enrollment
120
Registered
2005-10-06
Start date
2002-10-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic alopecia. Skin and Connective Tissue Diseases Androgenetic alopecia

Interventions

PSK 3841 solutions (2.5% or 5%).

Sponsors

ProStrakan Pharmaceuticals (France)
Lead Sponsor

Eligibility

Sex/Gender
Male

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

MeasureTime frame
1. Total and anagen hair numbers 2. Safety and tolerability

Secondary

MeasureTime frame
1. Investigator hair scalp assessment and patient hair growth questionnaire 2. Pharmacokinetics of PSK 3841 and its metabolites

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026