Long-term effect of NBUVB on Atopic Eczema Version 1
Research type
Research Study
Full title
Investigating the course of atopic eczema up to 1 year following completion of Narrowband UVB (NBUVB) phototherapy
IRAS ID
138517
Contact name
Shyamal Wahie
Contact email
Sponsor organisation
County Durham and Darlington NHS Foundation Trust
Research summary
Atopic eczema is a common itchy skin disease occurring in association with hay fever and asthma. Its prevalence is rising in industrialized countries and has considerable impact on the quality of life in affected patients.
NarrowBand UltraViolet B (NBUVB) phototherapy is the recommended second-line treatment for moderate-to-severe atopic eczema unresponsive to adequate topical therapy. It has been shown to induce good short-term improvement of eczema severity, however, the long-term effect is unclear. Specifically, it is unclear how patients fare with their eczema severity and eczema-related quality of life after completion of a standard course of NBUVB.
We aim to investigate the severity of atopic eczema 1 year following completion of NBUVB phototherapy, in adult patients with moderate-to-severe atopic eczema using validated scoring measures: objective SCORAD(SCORing Atopic Dermatitis) for disease severity and POEM (Patient-Oriented Eczema Measure) for eczema-related quality of life. Furthermore, the economic cost of treatment to both NHS and patients will be reviewed.
This is planned to be a multi-centre prospective observational pilot study involving sites of County Durham and Darlington NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust and Newcastle upon Tyne Hospitals NHS Foundation Trust. The sample size of 60 patients aims to provide us with about 25 to 30 patients for analysis at 1 year post UVB follow-up allowing anticipated estimates of 30% withdrawal from UVB and 30% loss to follow-up after UVB.
NBUVB will be administered twice weekly as per standard routine practice and patients will have their eczema severity and quality of life assessments undertaken by an unblinded investigator at baseline (i.e. just prior to commencing NBUVB), at the end of phototherapy treatment and at 4, 8 and 12 months after completion of NBUVB treatment. The recruitment period is anticipated to be over 15 months with a follow-up of over 30 months.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0444
Date of REC Opinion
24 Dec 2013
REC opinion
Further Information Favourable Opinion