Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSK 3841/1011
Study information
Scientific title
Acronym
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 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 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
Sponsor information
Organisation
ProStrakan Pharmaceuticals (France)
Sponsor details
102 Route de Noisy
Romainville
Paris
93230
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Proskelia Pharmaceuticals - a part of ProStrakan Pharmaceuticals.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|