Is the pulsed dye laser an effective adjuvant to topical therapy for psoriatic plaques?

ISRCTN ISRCTN28336586
DOI https://doi.org/10.1186/ISRCTN28336586
Secondary identifying numbers N0203173357
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

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Phone +44 (0)1392 402250

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPulsed 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) studiedPsoriasis
InterventionAim 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 typeOther
Primary outcome measurePulsed 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.
Secondary outcome measuresNot provided at time of registration
Overall study start date14/09/2005
Completion date14/06/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteria20 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 criteria1. 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 enrolment14/09/2005
Date of final enrolment14/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Devon and Exeter NHS Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan