Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2005
Date assigned
06/10/2005
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Evelyne Guénolé

ORCID ID

Contact details

7-9 Rue Jean Louis Bertrand
Rennes
35000
France

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Androgenetic alopecia.

Intervention

5% PSK 3841 solution or vehicle.

Intervention type

Drug

Phase

Not Specified

Drug names

PSK 3841

Primary outcome measures

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 trial start date

13/06/2002

Overall trial end date

20/09/2002

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.prostrakan.com

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes