Condition category
Skin and Connective Tissue Diseases
Date applied
01/05/2014
Date assigned
01/05/2014
Last edited
20/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Psoriasis is a skin condition that cases red, flaky, crusty patches of skin covered with silvery scales. It is a long-term, disabling condition that affects around 2% of the UK population. UVB (ultraviolet B) light is one of the few treatments which can clear psoriasis completely. Some patients then stay clear for months or even years. The most commonly used form of UVB treatment is narrowband UVB (NbUVB), which is effective in approximately 70% of patients. Many patients completing a course are ‘almost clear’ on discharge (often with just 1 or 2 small areas remaining), but clinical observation suggests that the psoriasis in these patients may come back quicker than in patients who clear completely. Understanding whether complete clearance of psoriasis is important for prolonged remission will inform effective management of psoriasis patients’ potentially providing longer disease remission, and with fewer treatment courses required overall. This may reduce the need for systemic treatment, lead to improved safety, and provide insights into mechanism of remission and relapse. The aim of this study is to find out whether patients whose psoriasis is 100% clear following a course of narrowband UVB have a longer duration of remission than those whose psoriasis was almost clear/didn’t clear.

Who can participate?
Adults who have long-term psoriasis and have been prescribed narrowband UVB treatment.

What does the study involve?
Patients who agree to participate attend three times weekly for phototherapy treatment (as for routine treatment). Before starting the course and at the end of the treatment they are asked to provide a blood sample, fill out a questionnaire (DLQI) and have their skin severity score (PASI) measured by nursing staff. The latter is also performed weekly when the patients attend for routine treatment. After 12-15 phototherapy treatments, patients with localised resistant plaques will be allocated at random to receive routine NbUVB or routine NbUVB plus 308nm Excimer treatment to these “resistant” plaques.

What are the possible benefits and risks of participating?
Benefits of participating include possibility of getting greater extent of clearance. Risks of participating are the same as for routine UVB treatment, and include erythema/ burning.

Where is the study run from?
Royal Victoria Infirmary (UK)

When is the study starting and how long is it expected to run for?
January 20134 to October 2016

Who is funding the study?
British Skin Foundation (UK)

Who is the main contact?
Dr Stamatina Verykiou
stamatina.verykiou@nuth.nhs.uk
Background and study aims

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stamatina Verykiou

ORCID ID

Contact details

County Durham and Darlington NHS Foundation Trust
North Road
Durham
DH1 5TW
United Kingdom
+44 1325 364271
stamatina.verykiou@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15935

Study information

Scientific title

Is the duration of remission of psoriasis increased after complete clearance versus 'almost complete' clearance following narrowband UVB phototherapy?

Acronym

Study hypothesis

Patients whose psoriasis is 100% clear following a course of narrowband UVB have a longer duration of remission than those whose psoriasis was almost clear/didn’t clear.

Ethics approval

North East - Newcastle & North Tyneside 1 Research Ethics Committee, 09/01/2014, ref: 13/NE/0357

Study design

Both; Interventional and Observational; Design type: Not specified, Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Dermatology; Subtopic: Skin (all Subtopics); Disease: Dermatology

Intervention

Patients will be given written information about the study and asked to give informed consent to participate. Patients will be given at least 48 hours to decide if they wish to participate. If they agree to take part demographic data will be collected, and the patients PASI and BMI recorded prior to the start of treatment. Demographic data will include the age that the patient first developed psoriasis, length of current episode/ flare, plaque size and presence of scalp involvement. We will also record any topical treatment that the patient has been using in the fortnight leading up to phototherapy. Patients will be asked to give a blood test prior to treatment (for CRP and vitamin D levels), and at the end of treatment period. Dermatology life quality index (DLQI) will be measured before treatment and after the treatment is complete.

Patients will then begin their routine NbUVB (narrow band ultraviolet B) treatment as per the normal protocol; weekly PASI scores will be recorded throughout treatment to assess their progress. After 15 treatments, patients still receiving treatment will be randomised to receive targeted narrowband UVB (308 Excimer Lamp) to up to 5 of the most treatment resistant plaques (usually the thickest plaques), or to be observed (see flow diagram below). Randomisation will be performed using SealedEnvelope.com (1:1). In our previous study 28% of patients were no longer having UVB treatment after 5 weeks (15 treatments), therefore we expect to have approximately 70% of recruited patients reaching 16 treatments. All patients will continue with their routine UVB until the end of the course (maximum of 30 treatments).10

At the end of the treatment period all patients will have their psoriasis area and severity (PASI) scores measured and will be given a diary to monitor any recurrence of psoriasis and any potential triggers for this (e.g sore throat, new medication etc). Patients will be telephoned on a monthly basis to ask about recurrence of psoriasis (we will text patients a reminder 24 hours before the phone call to confirm their telephone appointment). If this has been noted by the patient they will be assessed and their PASI measured. If they have a PASI of at least 50% of their pre-treatment level this will be defined as a relapse. If it is less than 50%, patients will be followed up on a monthly basis until relapse has occurred. It is expected that most patients will have relapsed within 12 months of treatment completion, although one study has had patients in remission for up to 22 months.1

Where possible all PASI scores will be measured by the same person, and when cover is required, a colleague experienced in measuring PASI scores will be asked to score the patient. Photographs will be taken of identified plaques of psoriasis before and after the 308nm Excimer Lamp treatment, as per standard protocol.

The expected study end date will be 2 years after the study begins. However as recruitment may take up to 1 year it is possible that we may need to extend the study by 6 months to allow for complete follow up of all patients.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Duration of remission achieved in psoriasis patients following a course of Narrowband UVB (NbUVB) ismeasured through monthly telephone calls after completion of treatment until study end. Patients are recalled and undergo a skin evaluation if psoriasis has flared.When >50% of the original PASI score is reached, the patients involvement in the study is complete.

Secondary outcome measures

1. Duration of remission achieved in patients who achieve “complete” clearance of psoriasis versus those who achieve “almost complete” clearance. Complete clearance was defined as 100%, and almost complete as 75-99% clear.
2. Practicality and effectiveness of the 308nm Excimer lamp in clearing more ‘resistant’ plaques alongside a standard course of NbUVB by nurse questionnaire

Overall trial start date

24/01/2013

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age of 18 years or older
2. Gives written informed consent to the study
3. Has chronic plaque psoriasis and has been routinely prescribed narrowband UVB

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Pregnancy
2. Patients on systemic treatment for psoriasis within the past 3 months
3. Patients with significant UV exposure over the past 1 month (sunny holidays /sunbeds etc)
4. Patients with a previous history of malignant skin cancer
5. Non-English speaking patients

Recruitment start date

24/04/2014

Recruitment end date

06/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle-upon-Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Skin Foundation

Alternative name(s)

BSF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Abstracts submitted to the British Association of Dermatologists (meeting July 2017). Planned publication in a high impact peer reviewed journal in approximately March 2018.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Sophie.weatherhead@nuth.nhs.uk

Intention to publish date

31/03/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/02/2017: The following changes have been made to the record: 1. The overall trial dates have been updated from 16/04/2014 - 01/02/2015 to 24/01/2013 - 31/10/2017 and the recuritment dates have been updated from 16/04/2014 - 01/02/2015 to 24/04/2014 - 06/03/2015 2. The hypothesis, interventions, outcome measures, trial participating centre, plain English summary, publication and dissemination plan and IPD sharing plan have been added. 07/02/2017: No publications found in PubMed, verifying study status with principal investigator.