ISRCTN80206075.

Trial name or title	Comparison of alitretinoin with PUVA as the first line treatment in patients with severe chronic hand eczema: a randomised controlled trial
Methods	Randomised open‐label parallel‐group design
Participants	500 to 780 participants with severe chronic hand eczema Inclusion criteria Aged ≥ 18 years at the time of signing the informed consent form Uncontrolled, severe chronic hand eczema defined as the presence of both of the following criteria:  PGA score of severe Resistance to treatment with potent topical corticosteroids for ≥ 4 weeks before the point of eligibility screening Avoidance strategies for known contact allergens in place for at least a 2‐week period before randomisation Has provided written informed consent  Expected to comply with treatment and protocol schedule Exclusion criteria An extensive list including skin‐related, treatment‐related, and general exclusion criteria
Interventions	Intervention • Alitretinoin 30 mg a day for 12 to 24 weeks • Immersion PUVA (twice weekly) for 12 to 24 weeks
Outcomes	Primary outcome of the trial Disease activity of the index hand, quantified by the HECSI tool, at 12 weeks post planned start of treatment Secondary outcomes of the trial Disease activity of the index hand, quantified by the HECSI tool, at 24 and 52 weeks post planned start of treatment Disease activity of the index hand, quantified by the mTLSS tool, at 24 and 52 weeks post planned start of treatment Disease activity of the index hand, quantified by the PGA tool at 24 and 52 weeks post planned start of treatment Time to relapse of the index hand (HECSI score > 75% baseline HECSI score of the index hand)  Time in remission of the index hand (defined by the period when the participant 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) Patient‐reported outcome using the DLQI tool, over the 52 weeks post planned start of treatment Patient‐reported outcome using the PBI‐HE over the 52 weeks post planned start of treatment PeDeSi over the 52 weeks post planned start of treatment Cost‐effectiveness over the 52 weeks post planned start of treatment
Starting date	01/01/2015
Contact information	Dr. Victoria Goss (Senior Trial Coordinator) ctru‐alpha@leeds.ac.uk
Notes	The study protocol is published at http://www.nihr.ac.uk/__data/assets/pdf_file/0005/136994/PRO‐12‐186‐01.pdf Sponsor: Unversity of Leeds (UK)