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

Background: the 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 findings: this 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. conclusions: silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. trial registration: current controlled trials isrctn77261365. © 2017 thomas et al.