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

ISRCTN	ISRCTN49873657
DOI	https://doi.org/10.1186/ISRCTN49873657
Secondary identifying numbers	PSK 3841/1011

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr Evelyne Guénolé
Scientific

7-9 Rue Jean Louis Bertrand
Rennes
35000
France

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	To assess the systemic and local safety and tolerance of 5% PSK 3841 solution versus vehicle (70% ethanol) when administered topically twice-a-day over 4 weeks on the scalp of Caucasian males with androgenic alopecia.
Ethics approval(s)	Not provided at time of registration
Condition	Androgenetic alopecia.
Intervention	5% PSK 3841 solution or vehicle.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	PSK 3841
Primary outcome measure	Safety and tolerability based on pharmacodynamic endocrine profile (gonadotropins, steroids) on day 1, 15 and 28 of treatment.
Secondary outcome measures	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 2. To assess whether an eventual exposure to PSK 3841 in untreated female partners occurred under real life conditions during the study
Overall study start date	13/06/2002
Overall study end date	20/09/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	A total of 30 couples (30 treated males, 30 untreated females).
Participant inclusion criteria	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
Participant exclusion criteria	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
Recruitment start date	13/06/2002
Recruitment end date	20/09/2002

7-9 Rue Jean Louis Bertrand

Rennes
35000
France

ProStrakan Pharmaceuticals (France)
Industry

102 Route de Noisy
Romainville
Paris
93230
France

Website	http://www.prostrakan.com
"ROR"	https://ror.org/03bvd4t69

Industry

Proskelia Pharmaceuticals - a part of ProStrakan Pharmaceuticals.

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan