Is the pulsed dye laser an effective adjuvant to topical therapy for psoriatic plaques?
| ISRCTN | ISRCTN28336586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28336586 |
| Protocol serial number | N0203173357 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Royal Devon and Exeter NHS Trust, NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 13/12/2013
- 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 Emily McGrath
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| Phone | +44 (0)1392 402250 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Pulsed dye laser treatments when used three times over three months with standard topical therapy effectively prevents recurrence of psoriatic plaques when compared to standard topical therapy alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Psoriasis |
| Intervention | Aim to recruit 20 patients. Informed consent will be obtained. Two symmetrical, similar plaques will be selected by the investigator and randomly allocated to either topical therapy alone, or topical therapy and the pulsed dye laser treatment. The lesions will be photographed, measured and scored according to the validated Psoriasis Area Severity Index (PASI). Both plaques will be treated with Dovobet ointment twice daily for four weeks, after which the plaque allocated to laser treatment would be treated with a short pulse width (500 microseconds) pulsed dye laser once monthly for three months, in addition to standard topical therapy (Dovonex ointment twice daily). The control plaques would be treated with standard topical therapy throughout. At the end of the treatment period, plaques would be examined by an investigator blinded to the treatment groups. The skin would be photographed and any residual lesion measured and scored according to the modified PASI score by an assessor blinded to the treatment groups. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pulsed dye laser treatments when used three times over three months with standard topical therapy effectively prevents recurrence of psoriatic plaques when compared to standard topical therapy alone. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 14/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 patients with chronic plaque psoriasis, who are on topical treatment only and have symmetrical plaques on legs between 2 and 5 cm in diameter. |
| Key exclusion criteria | 1. Patients under 18 or over 80 years of age 2. Patients who have had systemic or ultraviolet light therapy within past 4 weeks 3. Patients who are unable to attend the laser unit on the six occasions needed |
| Date of first enrolment | 14/09/2005 |
| Date of final enrolment | 14/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
