Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203173357
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
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
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/09/2005
Overall trial end date
14/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant 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
Recruitment start date
14/09/2005
Recruitment end date
14/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Devon and Exeter NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
Basic results (scientific)
Publication list