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. and Bradshaw, Lucy E. and Sach, Tracey H. and Batchelor, Jonathan M. and Lawton, Sandra and Harrison, Eleanor F. and Haines, Rachel H. and Ahmed, Amina and Williams, Hywel C. and Dean, Taraneh and Burrows, Nigel P. and Pollock, Ian and Llewellyn, Joanne and Crang, Clare and Grundy, Jane D. and Guiness, Juliet and Gribbin, Andrew and Mitchell, Eleanor J. and Cowdell, Fiona and Brown, Sara J. and Montgomery, Alan A. (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). e1002280/1-e1002280/23. ISSN 1549-1277

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Abstract

Background

The role of clothing in the management of eczema (syn. atopic dermatitis, 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 years with moderate to severe eczema were recruited from secondary care and the community in five UK centres. Participants were allocated using on-line randomisation (1:1) to standard care, or standard care plus silk garments; stratified by age and recruiting centre. Silk garments were worn for 6 months. Primary outcome (eczema severity) was assessed at baseline, 2, 4 and 6 months, by nurses blinded to treatment allocation using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). Safety outcome: number of skin infections. Three hundred children were randomised (26th Nov 2013 to 5th May 2015): 42% girls, 79% white, mean age 5 years. 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 months were 9·2, 6·4, 5·8, 5·4 for silk clothing and 8·4, 6·6, 6·0, 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). This confidence interval is equivalent to a difference of -1·5 to 0·5 in the original EASI scale units which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) for silk clothing and standard care respectively. Even if the small observed treatment effect was genuine, the incremental cost per QALY was £56,881 in the base case analysis from an NHS perspective, suggesting that silk garments are unlikely to be cost-effective within currently accepted thresholds. Main limitations: whilst minimising detection bias, use of an objective primary outcome may have underestimated treatment effects.

Conclusions

Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.

Item Type: Article
Additional Information: Authors on behalf of the UK Dermatology Clinical Trials Network’s CLOTHES Trial Team.
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: 10.1371/journal.pmed.1002280
Depositing User: Eprints, Support
Date Deposited: 06 Mar 2017 14:17
Last Modified: 13 Oct 2017 01:36
URI: http://eprints.nottingham.ac.uk/id/eprint/41097

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