Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2005
Date assigned
06/10/2005
Last edited
19/02/2014
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 Dominique Van Heste

ORCID ID

Contact details

9 Rue du Sondard
Tournai
7500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSK 3841/2001

Study information

Scientific title

Acronym

Study hypothesis

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

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

PSK 3841 solutions (2.5% or 5%).

Intervention type

Drug

Phase

Not Specified

Drug names

PSK 3841

Primary outcome measures

1. Total and anagen hair numbers
2. Safety and tolerability

Secondary outcome measures

1. Investigator hair scalp assessment and patient hair growth questionnaire
2. Pharmacokinetics of PSK 3841 and its metabolites

Overall trial start date

20/10/2002

Overall trial end date

04/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

120

Participant exclusion criteria

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

Recruitment start date

20/10/2002

Recruitment end date

04/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

9 Rue du Sondard
Tournai
7500
Belgium

Sponsor information

Organisation

ProStrakan Pharmaceuticals (France)

Sponsor details

102 Route de Noisy
Romainville
Paris
932230
France

Sponsor type

Industry

Website

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