The Rapid Eczema Trials’ Keep Control of Eczema Study: Specific advice on topical corticosteroid treatment duration for eczema flares versus usual care in adults and children. Protocol of an online, randomised controlled trial

<ns3:p>Background A systematic review of international guidelines for eczema (syn. atopic dermatitis) highlighted variable recommendations for using topical corticosteroid (TCS), reflecting limited randomised controlled trial (RCT) evidence to inform practice. The Rapid Eczema Trials project is a novel programme delivering multiple online RCTs working with members of the public to co-design studies that answer questions of importance to them. The Keep Control of Eczema Study evaluates whether providing specific advice on how long to apply TCS for during an eczema flare-up improves eczema control compared to usual care, over 16 weeks. Methods This is an online, two-arm, parallel-group superiority RCT. Individuals are eligible if aged ≥1 year, live in the UK, have used TCS on at least three days for eczema flares in the past 8 weeks, and are willing to change how they use their TCS. Participants are excluded if using a TCS preparation with antibiotics/antifungal, unlikely to have atopic eczema, eczema only present on the scalp and/or sensitive body sites, and using very strong TCS. Participants are randomised 1:1 to either: 1) specific advice to treat eczema flares for slightly longer or 2) treat as usual. Those allocated to the treat for longer group are asked to use TCS for 2 days after the skin looks/feels eczema-free. Primary outcome is eczema control measured by Recap of atopic eczema (RECAP) assessed weekly over 16 weeks. Secondary outcomes: Patient Oriented Eczema Measure (POEM), days of TCS use and skin specific quality of life, number of weeks when TCS not used, number of well controlled weeks, global change in eczema and safety outcomes. Some participants will be invited to a semi-structured interview to discuss their experience. The primary analysis will be conducted according to randomised allocation regardless of adherence to allocated TCS strategy during a flare-up. Trial registration: Prospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) 29214215. DOI: https://doi.org/10.1186/ISRCTN29214215</ns3:p>