Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial)

Abstract

BackgroundThe role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease.Methods and findingsThis was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections.Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of −1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.ConclusionsSilk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.Trial registrationCurrent Controlled Trials ISRCTN77261365

Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I

“…Smooth clothing and avoidance of irritating fabrics and fibres are essential in the avoidance of primary skin irritation. Silk garments with an AEGIS‐coating are lightweight and comfortable to wear, but do not improve eczema severity over standard of care treatment . Too occlusive clothing inducing heat sensations should be avoided.…”

How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods

“…Children aged 1–15 years were recruited from secondary care and the community and allocated to wear either silk garments plus standard care or standard care only. At study entry, one of the eligibility criteria was that participants had either a moderate (9–11) or severe (12–15) score on the Nottingham Eczema Severity Score …”

“…Using the dataset from the CLOTHES trial, which was a 6‐month randomized controlled trial to assess wearing silk clothing compared with usual care in children with moderate‐to‐severe eczema, the present study aimed to: (i) calculate the smallest detectable change in the POEM; (ii) estimate the MIC of the POEM by repeating methods used in previous studies and using additional methods; and (iii) assess whether using a patient/parent or investigator static global assessment as an anchor influences the anchor‐based MIC estimates.…”

Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II

“…Some of these newer options are still under investigation and there seems to be some concern about the safety of silver‐coated textiles in infants and toddlers. AEGIS‐coated silk textiles did not show clinical benefit in a well‐controlled, multicenter clinical trial …”