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ISRCTN
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ISRCTN49873657
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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PSK 3841/1011
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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France
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Disease/condition/study domain
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Androgenetic alopecia.
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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13/06/2002
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Anticipated end date
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20/09/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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A total of 30 couples (30 treated males, 30 untreated females).
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Interventions
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5% PSK 3841 solution or vehicle.
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Primary outcome measure(s)
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Safety and tolerability based on pharmacodynamic endocrine profile (gonadotropins, steroids) on day 1, 15 and 28 of treatment.
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Secondary outcome measure(s)
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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
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Sources of funding
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Proskelia Pharmaceuticals - a part of ProStrakan Pharmaceuticals.
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Trial website
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Publications
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Contact name
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Dr
Evelyne
Guénolé
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Address
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7-9 Rue Jean Louis Bertrand
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City/town
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Rennes
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Zip/Postcode
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35000
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Country
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France
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Sponsor
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ProStrakan Pharmaceuticals (France)
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Address
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102 Route de Noisy
Romainville
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City/town
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Paris
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Zip/Postcode
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93230
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Country
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France
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Sponsor website:
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http://www.prostrakan.com
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Date applied
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12/09/2005
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Last edited
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14/02/2008
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Date ISRCTN assigned
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06/10/2005
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