Title: Observer blind randomised controlled pilot study comparing localised hand PUVA with localised hand narrowband UVB for the treatment of hand eczema.
Funder: Department of Health (England)

Abstract: Background Hand eczema is a very common chronic skin condition with a prevalence of 12 to 14% and an estimated incidence of 5.53-8.8 per 100 person yrs. It reduces quality of life and causes occupational health problems (Fowler et al) .If creams fail, the next options are either PUVA involving a drug, psoralen(P), followed by exposure to Ultraviolet A (UVA) radiation (light), immunosuppressive drugs or alitretinoin, another tablet. Repeated courses of PUVA can cause skin cancer. PUVA is currently the phototherapy of choice but is not supported by evidence. The use of UVB is safer, does not require any additional drug use, appears to be as effective and is easier to deliver. Our department has a strong record in completing high impact phototherapy studies and is well placed to investigate this. Aims A number of small case series and studies have suggested that narrowband UVB light treatment, requiring no other medication, may be as effective for severe hand eczema as PUVA. We aim to perform a randomised observer blind pilot study to estimate key parameters to plan a subsequent definitive trial of PUVA vs narrowband UVB for the treatment of hand eczema. Specifically this pilot study will provide data to allow us to determine willingness to be randomised, recruitment, retention and response rates. It will pilot the collection of primary and secondary outcome measures to assess data quality and yield. The pilot study will test the integrity of the study protocol, will clarify inclusion/exclusion criteria and will test data collection procedures and staff training needs. Plan of Investigation Patients with hand eczema, referred for consideration of hand PUVA , will be invited to participate. Eligible patients will be randomised to receive either PUVA or narrowband UVB. The severity of the hand eczema will be determined using a validated scoring system for hand eczema. The trial will aim to replicate clinical practice where possible and the exit criteria will be either complete clearance or 24 treatments which will be the maximum. The primary outcome will be the proportion of patients responding (achieving clear or almost clear) in each treatment group. Secondary outcome measures will be (1) the impact on patient quality of life, (2) the relative health economic benefits of the treatments. Potential Impact Studies have shown that repeated courses of whole body PUVA increase the risk of developing skin cancer. The precise risk with hand PUVA is unknown but concerns regarding skin cancer limit the use of PUVA for hand eczema patients. Psoralen can be taken orally but is more commonly applied locally by immersing the hands in a psoralen solution. Systemic treatments all have side effects. Alitretinoin is a potent teratogen. Systemic immunosuppressive drugs all have significant potential side effects including organ damage and malignancy. UVB requires no systemic drugs and would be safer than all the other options, have fewer side effects, would reduce nursing time and may cost less. Home whole body UVB works well in some areas of Scotland and this model could be adapted for hand UVB.


Research activity codes: 6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: SKIN