A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Abstract

BackgroundEczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that ‘silk therapeutic garments plus standard eczema care’ is superior to ‘standard care alone’ for children with moderate to severe eczema.Methods/DesignParallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months’ duration.Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners.Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child’s age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete.Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series.Trial registrationCurrent Controlled Trials ISRCTN77261365 (registered 11 November 2013).

A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

“…A MCID for primary care has not formally been established, but a recent primary care trial, in which children had lower baseline POEM scores than in the CREAM trial, assumed a MCID of 2, 80 and a recent secondary care trial has assumed a MCID of 3. 81 However, even if we adopt the most conservative MCID of 2, our results still suggest no clinically important benefit at 2 weeks from either oral or topical antibiotics for clinically suspected infected flares of eczema in children. The 95% CIs for the effect sizes at 4 weeks and 3 months do include the possibility of a POEM score that is lower (beneficial) in both intervention arms by more than 3, and the estimate of effect of oral antibiotic at 3 months on the POEM score had a 95% CI that went down to -4.3.…”

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

“…41 Only participants of white European ethnicity were included in the FLG genotype subgroup analysis because FLG mutations are known to be ethnically specific. Individuals in whom the four most prevalent mutations (R501X, 2282del4, R2447X and S3247X) were successfully genotyped were categorised as FLG wild type (none of the prevalent mutations was identified; these individuals constituted the control cohort), FLG heterozygotes (carrying one FLG null mutation) or FLG homozygotes or compound heterozygotes (individuals carrying two FLG null mutations).…”

Scoping systematic review of treatments for eczema

“…The CLOTHing for the relief of Eczema Symptoms (CLOTHES) trial (ref. HTA 11/65/01) 346 is currently running in the UK, comparing the addition of silk clothing to normal eczema treatment against normal eczema treatment alone.…”