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ISRCTN
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ISRCTN71083772
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ClinicalTrials.gov identifier
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Public title
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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%)
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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 3841/2001
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Study hypothesis
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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
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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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United Kingdom
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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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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
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Participants - exclusion criteria
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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
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Anticipated start date
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20/10/2002
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Anticipated end date
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04/08/2003
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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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120
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Interventions
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PSK 3841 solutions (2.5% or 5%).
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Primary outcome measure(s)
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1. Total and anagen hair numbers
2. Safety and tolerability
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Secondary outcome measure(s)
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1. Investigator hair scalp assessment and patient hair growth questionnaire
2. Pharmacokinetics of PSK 3841 and its metabolites
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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
Dominique
Van Heste
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Address
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9 Rue du Sondard
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City/town
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Tournai
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Zip/Postcode
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7500
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Country
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Belgium
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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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932230
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Country
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France
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Date applied
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12/09/2005
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Last edited
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11/02/2011
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Date ISRCTN assigned
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06/10/2005
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