Treatment of psoriasis by pulsed dye lasers: short-term and long-term (4 years) results

ISRCTN	ISRCTN66115464
DOI	https://doi.org/10.1186/ISRCTN66115464
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Jean Michel Mazer
Scientific

Centre Laser Trevise
49 rue de Trevise
Paris
75009
France

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	The study was approved by the local ethics committee (CCPPRB Paris Saint-Louis) on 21st April 2001 (ref: 2001/13)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/09/2002
Completion date	02/10/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	28
Key inclusion criteria	1. Both males and females, minimum age = 18, no upper age limit 2. Psoriasis: chronic and untreated plaques
Key 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)
Date of first enrolment	02/09/2002
Date of final enrolment	02/10/2008

Centre Laser Trevise

Paris
75009
France

Saint Louis Hospital (France)
Hospital/treatment centre

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

Website	http://www.chu-stlouis.fr
"ROR"	https://ror.org/049am9t04

Hospital/treatment centre

Saint Louis Hospital (France)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan