Condition category
Skin and Connective Tissue Diseases
Date applied
18/06/2008
Date assigned
30/09/2008
Last edited
30/09/2008
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 Jean Michel Mazer

ORCID ID

Contact details

Centre Laser Trevise
49 rue de Trevise
Paris
75009
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Previous studies with pulsed dye lasers showed improvement of chronic plaques of psoriasis and, sometimes, total clearing. This study aims to investigate the efficacy of the pulsed dye laser treatment on psoriasis plaques by comparing the affected areas that have been treated with the laser against the untreated area within an individual.

Ethics approval

The study was approved by the local ethics committee (CCPPRB Paris Saint-Louis) on 21st April 2001 (ref: 2001/13)

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

Psoriasis

Intervention

Two plaques were investigated in each patient, and for both plaques, 1/4 of the total area was left untreated (control area). The remaining area of both plaques were treated with the pulsed dye laser.

Randomisation: The plaques were divided in four quadrants and, by draw (throwing a four sided dice), one quadrant was chosen as the control area and the other three were treated.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical score at baseline and 6 weeks after the last and third treatment by pulsed dye laser.

Secondary outcome measures

Adverse effects, followed-up for at least 2 years.

Overall trial start date

02/09/2002

Overall trial end date

02/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, minimum age = 18, no upper age limit
2. Psoriasis: chronic and untreated plaques

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

28

Participant exclusion criteria

1. Pregnant women
2. Minors
3. Patients who had received local treatment during the last month or oral treatment during the last 6 weeks (cyclosporin, retinoids, methotrexate, corticosteroids)

Recruitment start date

02/09/2002

Recruitment end date

02/10/2008

Locations

Countries of recruitment

France

Trial participating centre

Centre Laser Trevise
Paris
75009
France

Sponsor information

Organisation

Saint Louis Hospital (France)

Sponsor details

c/o Prof L Dubertret
Department of Dermatology
Paris
75010
France

Sponsor type

Hospital/treatment centre

Website

http://www.chu-stlouis.fr

Funders

Funder type

Hospital/treatment centre

Funder name

Saint Louis Hospital (France)

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