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%)

ISRCTN	ISRCTN71083772
DOI	https://doi.org/10.1186/ISRCTN71083772
Protocol serial number	PSK 3841/2001
Sponsor	ProStrakan Pharmaceuticals (France)
Funder	Proskelia Pharmaceuticals - a part of ProStrakan Pharmaceuticals.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Dominique Van Heste
Scientific

9 Rue du Sondard
Tournai
7500
Belgium

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The hypotheses underlying this study were: 1. Once-daily treatment with PSK 3841 solution at 5% was to result in a significant increase in hair growth, when compared to daily treatment with vehicle 2. There should be a difference between the two active treatments (2.5% and 5% once-a-day) 3. Treatments should be safe and well tolerated in men with male pattern baldness
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Androgenetic alopecia.
Intervention	PSK 3841 solutions (2.5% or 5%).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	PSK 3841
Primary outcome measure(s)	1. Total and anagen hair numbers 2. Safety and tolerability
Key secondary outcome measure(s)	1. Investigator hair scalp assessment and patient hair growth questionnaire 2. Pharmacokinetics of PSK 3841 and its metabolites
Completion date	04/08/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	20/10/2002
Date of final enrolment	04/08/2003

9 Rue du Sondard

Tournai
7500
Belgium

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan