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 |
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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
Scientific
7-9 Rue Jean Louis Bertrand
Rennes
35000
France
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- France
Study participating centre
7-9 Rue Jean Louis Bertrand
Rennes
35000
France
35000
France
Sponsor information
ProStrakan Pharmaceuticals (France)
Industry
Industry
102 Route de Noisy
Romainville
Paris
93230
France
Website | http://www.prostrakan.com |
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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 | |
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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 |