Treatment of psoriasis by pulsed dye lasers: short-term and long-term (4 years) results
ISRCTN | ISRCTN66115464 |
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DOI | https://doi.org/10.1186/ISRCTN66115464 |
Secondary identifying numbers | N/A |
- Submission date
- 18/06/2008
- Registration date
- 30/09/2008
- Last edited
- 30/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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
Contact information
Dr Jean Michel Mazer
Scientific
Scientific
Centre Laser Trevise
49 rue de Trevise
Paris
75009
France
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- France
Study participating centre
Centre Laser Trevise
Paris
75009
France
75009
France
Sponsor information
Saint Louis Hospital (France)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof L Dubertret
Department of Dermatology
Paris
75010
France
Website | http://www.chu-stlouis.fr |
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https://ror.org/049am9t04 |
Funders
Funder type
Hospital/treatment centre
Saint Louis Hospital (France)
No information available
Results and Publications
Intention to publish date | |
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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 |