title: Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).
abstract: 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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN77261365.
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Kim S
authors.initials: KS
authors.lastname: Thomas
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Lucy E
authors.identifier: http://orcid.org/0000-0001-8382-6040
authors.initials: LE
authors.lastname: Bradshaw
authors.affiliation: Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.
authors.forename: Tracey H
authors.identifier: http://orcid.org/0000-0002-8098-9220
authors.initials: TH
authors.lastname: Sach
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Jonathan M
authors.identifier: http://orcid.org/0000-0002-7728-2021
authors.initials: JM
authors.lastname: Batchelor
authors.affiliation: Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom.
authors.forename: Sandra
authors.initials: S
authors.lastname: Lawton
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Eleanor F
authors.identifier: http://orcid.org/0000-0003-0652-3980
authors.initials: EF
authors.lastname: Harrison
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Rachel H
authors.identifier: http://orcid.org/0000-0001-7924-0602
authors.initials: RH
authors.lastname: Haines
authors.affiliation: Patient and Public Involvement Representative, Nottingham, United Kingdom.
authors.forename: Amina
authors.initials: A
authors.lastname: Ahmed
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Hywel C
authors.identifier: http://orcid.org/0000-0002-5646-3093
authors.initials: HC
authors.lastname: Williams
authors.affiliation: Faculty of Science, University of Portsmouth, Portsmouth, United Kingdom.|University of Brighton, Brighton, United Kingdom.
authors.forename: Taraneh
authors.initials: T
authors.lastname: Dean
authors.affiliation: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.
authors.forename: Nigel P
authors.initials: NP
authors.lastname: Burrows
authors.affiliation: Royal Free London NHS Foundation Trust, Barnet Hospital, Barnet, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Pollock
authors.affiliation: Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom.
authors.forename: Joanne
authors.identifier: http://orcid.org/0000-0002-0265-6025
authors.initials: J
authors.lastname: Llewellyn
authors.affiliation: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.
authors.forename: Clare
authors.identifier: http://orcid.org/0000-0002-8582-2438
authors.initials: C
authors.lastname: Crang
authors.affiliation: Isle of Wight NHS Trust, St. Mary's Hospital, Newport, United Kingdom.
authors.forename: Jane D
authors.initials: JD
authors.lastname: Grundy
authors.affiliation: Royal Free London NHS Foundation Trust, Barnet Hospital, Barnet, United Kingdom.
authors.forename: Juliet
authors.initials: J
authors.lastname: Guiness
authors.affiliation: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.
authors.forename: Andrew
authors.identifier: http://orcid.org/0000-0002-1183-4057
authors.initials: A
authors.lastname: Gribbin
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Eleanor J
authors.identifier: http://orcid.org/0000-0002-6998-4533
authors.initials: EJ
authors.lastname: Mitchell
authors.affiliation: Faculty of Health Education and Life Sciences, Birmingham City University, Birmingham, United Kingdom.
authors.forename: Fiona
authors.identifier: http://orcid.org/0000-0002-9355-8059
authors.initials: F
authors.lastname: Cowdell
authors.affiliation: Skin Research Group, University of Dundee, Dundee, United Kingdom.|Department of Dermatology, Ninewells Hospital and Medical School, Dundee, United Kingdom.
authors.forename: Sara J
authors.identifier: http://orcid.org/0000-0002-3232-5251
authors.initials: SJ
authors.lastname: Brown
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Alan A
authors.identifier: http://orcid.org/0000-0003-0450-1606
authors.initials: AA
authors.lastname: Montgomery
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003020:Clothing; D004485:Eczema / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012720:Severity of Illness Index; D047011:Silk; D016037:Single-Blind Method; D059039:Standard of Care; D016896:Treatment Outcome
chemical_list: D047011:Silk