Skip to main content

Research Repository

Advanced Search

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

Thomas, Kim S.; Bradshaw, Lucy E.; Sach, Tracey H.; Batchelor, Jonathan M.; Lawton, Sandra; Harrison, Eleanor F.; Haines, Rachel H.; Ahmed, Amina; Williams, Hywel C.; Dean, Taraneh; Burrows, Nigel P.; Pollock, Ian; Duley, Lelia; Llewellyn, Joanne; Crang, Clare; Grundy, Jane D.; Guiness, Juliet; Gribbin, Andrew; Mitchell, Eleanor J.; Cowdell, Fiona; Brown, Sara J.; Montgomery, Alan A.; Jadowski, Andrew; White, Jennifer; Walker, Sarah; Clarke, Tessa; McCready, Sharon; Hepburn, Trish; Simpkins, Daniel; Fenty, Justin; Murphy, Lucinda; Watson, Rachel; Buckley, Hannah; Rumsey, Chris; Aspland, Jo; Glasbey, Gill; Wake, Eileen; McLean, Irwin; Harding, Rachel; MacCallum, Stephanie

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


Authors

Tracey H. Sach

Jonathan M. Batchelor

Sandra Lawton

Rachel H. Haines

Amina Ahmed

Profile image of HYWEL WILLIAMS

HYWEL WILLIAMS HYWEL.WILLIAMS@NOTTINGHAM.AC.UK
Professor of Dermato-Epidemiology

Taraneh Dean

Nigel P. Burrows

Ian Pollock

Lelia Duley

Joanne Llewellyn

Clare Crang

Jane D. Grundy

Juliet Guiness

Andrew Gribbin

Fiona Cowdell

Sara J. Brown

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Andrew Jadowski

Sarah Walker

Tessa Clarke

Sharon McCready

TRISH HEPBURN Trish.Hepburn@nottingham.ac.uk
Senior Medical Statistician

Daniel Simpkins

Justin Fenty

Lucinda Murphy

Rachel Watson

Hannah Buckley

Chris Rumsey

Jo Aspland

Gill Glasbey

Eileen Wake

Irwin McLean

Rachel Harding

Stephanie MacCallum



Abstract

© 2017 Thomas et al. 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.

Citation

Thomas, K. S., Bradshaw, L. E., Sach, T. H., Batchelor, J. M., Lawton, S., Harrison, E. F., …MacCallum, S. (2017). Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLoS Medicine, 14(4), Article e1002280. https://doi.org/10.1371/journal.pmed.1002280

Journal Article Type Article
Acceptance Date Mar 2, 2017
Online Publication Date Apr 11, 2017
Publication Date Apr 11, 2017
Deposit Date Mar 6, 2017
Publicly Available Date Apr 11, 2017
Journal PLoS Medicine
Print ISSN 1549-1277
Electronic ISSN 1549-1676
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 14
Issue 4
Article Number e1002280
DOI https://doi.org/10.1371/journal.pmed.1002280
Public URL https://nottingham-repository.worktribe.com/output/855790
Publisher URL http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002280
Additional Information Authors on behalf of the UK Dermatology Clinical Trials Network’s CLOTHES Trial Team.
Contract Date Mar 6, 2017

Files





You might also like



Downloadable Citations