Condition category
Skin and Connective Tissue Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
13/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emily McGrath

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 402250

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes