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
Submission date
12/09/2005
Registration date
06/10/2005
Last edited
14/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Evelyne Guénolé
Scientific

7-9 Rue Jean Louis Bertrand
Rennes
35000
France

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study hypothesisTo 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
ConditionAndrogenetic alopecia.
Intervention5% PSK 3841 solution or vehicle.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)PSK 3841
Primary outcome measureSafety and tolerability based on pharmacodynamic endocrine profile (gonadotropins, steroids) on day 1, 15 and 28 of treatment.
Secondary outcome measures1. 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 date13/06/2002
Overall study end date20/09/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA total of 30 couples (30 treated males, 30 untreated females).
Participant inclusion criteriaFor 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 criteriaFor 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 date13/06/2002
Recruitment end date20/09/2002

Locations

Countries of recruitment

  • France

Study participating centre

7-9 Rue Jean Louis Bertrand
Rennes
35000
France

Sponsor information

ProStrakan Pharmaceuticals (France)
Industry

102 Route de Noisy
Romainville
Paris
93230
France

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

Funders

Funder type

Industry

Proskelia Pharmaceuticals - a part of ProStrakan Pharmaceuticals.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan