Condition category
Skin and Connective Tissue Diseases
Date applied
01/05/2014
Date assigned
01/05/2014
Last edited
02/05/2014
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 Stamatina Verykiou

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15935

Study information

Scientific title

Acronym

Predicting remission of psoriasis after phototherapy

Study hypothesis

Psoriasis is a chronic disabling inflammatory skin condition affecting 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/even years. The commonest form of UVB treatment is narrowband UVB (NbUVB), effective in 70% of patients. Many patients completing a course are ‘almost clear’ on discharge, but clinical observation suggests that the psoriasis in these patients may come back quicker than in patients who clear completely.

Psoriasis improves faster, when higher exposures of UVB are given. Although psoriatic areas tolerate this well, adjacent uninvolved skin burn, so in routine UVB treatment when the patients’ whole body is exposed, the amount of UVB given per treatment session is limited. Recently a 308nm Excimer Lamp was developed which targets individual patches of psoriasis using medium/ high dose NbUVB, while avoiding exposure of adjacent skin. During treatment, there are often areas of psoriasis which are slower to clear/ more resistant to treatment. We will assess the adjunctive use of the 308nm Excimer Lamp to these “resistant” areas during routine NbUVB treatment, in an attempt to improve clearance. During phototherapy, 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. Main outcome of the study will be to see if this extra treatment influences the time patients remain clear after stopping treatment. Patients will be followed up until relapse or up to 18 months following end of their course of phototherapy. Other measures will include assessment of whether baseline clinical and/or laboratory factor predict improvement/ duration of remission.
Understanding if complete clearance of psoriasis is important for prolonged remission will inform effective management of psoriasis patients’ potentially providing longer disease remission.

Ethics approval

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

UVB, Narrowband UVB 3 times weekly

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Duration of complete psoriasis clearance after phototherapy; Timepoint(s): Up to 18 months post treatment

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/04/2014

Overall trial end date

01/02/2015

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

16/04/2014

Recruitment end date

01/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
Durham
DH1 5TW
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 (UK) The; Grant Codes: S905

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