Title: Randomised controlled trial of silk therapeutic clothing for the long-term management of eczema in children (CLOTHES Trial: CLOTHing for the relief of Eczema Symptoms)
Funder: Department of Health (England)

Abstract: DESIGN: A pragmatic observer-blind parallel group RCT to evaluate the addition of silk therapeutic clothing to standard eczema care. Primary outcome will be assessed over six months after which time control participants will also be given clothing and followed-up for a further two months. This follow-up phase serves to i) enhance recruitment; ii) reduce loss to follow-up & contamination of the intervention in the control group; and iii) assess adherence in normal practice.An internal pilot will assess recruitment retention and adherence. Main success criteria are recruitment & retention to target (min 70% of target at six months of recruitment). Families from the pilot phase will be asked to take part in focus group sessions in order to identify factors that might influence the use of silk clothing in normal practice. Barriers to implementation will also be explored through structured interviews with health professionals and commissioners.SETTING: Secondary care primary care and the wider community via direct advertising. Recruitment and assessment visits will take place in five hospitals with a proven track record of recruiting into eczema trials. TARGET POPULATION: Children aged 6 months to 15 years with moderate to severe childhood eczema. The main clinical burden is in younger children (<7 yrs) but we will not exclude older children if they wish to participate.INTERVENTION: Knitted sericin-free silk therapeutic garments with a CE mark for use in eczema (DermaSilkTM and DreamSkinTM) to be worn at night and when possible during the day. Both products will be included in the trial in order to limit commercial advantage to one particular company. The control group will receive standard advice about clothing (e.g. avoidance of wool) but will not be recommended specific products. All participants will continue with their standard eczema care from their normal care provider (in primary or secondary care as appropriate). OUTCOMES: Primary outcome: eczema severity over six months assessed by a blinded nurse using a validated objective scale (Six Area Six Signs Atopic Dermatitis Scale – SASSAD). Use of an objective outcome is important for the primary outcome as it will not be possible to blind the treatment. Secondary outcomes include: global assessment (patient & nurse); Three Item Severity (TIS); use of topical therapy (corticosteroids calcineurin inhibitors and days in wet wraps); patient oriented eczema measure (POEM); number of skin infections; durability acceptability of the clothing (parent & child); adherence;health-related quality of life and cost-effectiveness. These are in line with the core domains recommended by the Harmonizing Outcome Measures for Eczema (HOME) initiative (eczema signs symptoms long-term control and quality of life).ECONOMIC EVALUATION: An incremental cost analysis will be conducted from an NHS and a family perspective. Health and family resource use data will be collected using patient diaries and valued using published unit costs or patient reported estimates. Incremental costs will be combined with a range of benefits including both disease specific measures to undertake within-trial cost-effectiveness analysis and health utility measures to estimate the cost-utility of silk clothing. Sensitivity analysis will be undertaken to quantify uncertainty.


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: SKIN