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
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