Comparing treatments for severe chronic hand eczema

INTERVENTION: A maximum of 780 consenting participants with severe CHE will be randomised on a 1:1 basis to receive either Alitretinoin (30 mg per day) or the phototherapy Psoralen with UV‐A treatment (PUVA) (twice weekly) in conjunction with concomitant topical corticosteroids, emollients and patient education. PUVA therapy will involve photosensitising of hands by immersion in a dilute solution of Meladinine®, before exposure of hands to UV‐A light. The trial is an adaptive design with a planned interim analysis to re‐estimate the sample size, which may lead to fewer than the required 780 participants, although a minimum of 500 participants will be recruited. CONDITION: Severe, chronic hand eczema ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: Disease activity of the index hand, quantified using the HECSI tool, at 12 weeks post planned start of treatment SECONDARY OUTCOME: 1. Disease activity of the index hand, quantified using the HECSI tool, at 24 and 52 weeks post planned start of treatment; 2. Disease activity of the index hand, quantified using the mTLSS tool, at 24 and 52 weeks post planned start of treatment; 3. Disease activity of the index hand, quantified using the PGA tool at 24 and 52 weeks post planned start of treatment; 4. Time to relapse of the index hand (HECSI score >75% baseline HECSI score of the index hand) ; 5. Time in remission of the index hand (defined by the period of time when patient is classed as clear/almost clear until the disease is scored as ‘mild’ or higher on the PGA scale and participants have been using topical corticosteroids daily for the previous 7 or more days); 6. Patient reported outcome using the DLQI tool, over the 52 weeks post planned start of treatment; 7. Patient reported outcome using the PBI‐HE over the 52 weeks post planned start of treatment; 8. PeDeSi over the 52 weeks post planned start of treatment; 9. Cost‐effectiveness over the 52 weeks post planned start of treatment INCLUSION CRITERIA: 1. Patients aged =18 years at the time of signing the Informed Consent Form 2. Patients suffering from uncontrolled, severe CHE defined as the presence of both of the following criteria: 2.1. PGA score of severe 2.2. Resistance to treatment with potent topical corticosteroids for = 4 weeks prior to the point of eligibility screening 3. Avoidance strategies for known contact allergens are in place for at least a two‐week period prior to randomisation 4. Patient has provided written informed consent 5. Patient is expected to comply with treatment and protocol schedule