CLOTHES Trial

Design and population. The CLOTHES trial (Thomas et al., PLoS Med 2017) was a parallel-group, observer-blind, pragmatic RCT at five UK centres, recruiting from hospital clinics and the community. Between 2013 and 2015 it randomised 300 children aged 1–15 (mean age 5; 42% girls) with moderate to severe Atopic Dermatitis. It was NIHR-funded and tested a popular but costly product: close-fitting therapeutic silk garments, marketed as smooth and antimicrobial. CLOTHES Trial [relates] Atopic Dermatitis

Intervention and primary outcome. Children got standard care plus silk garments to wear for 6 months, or standard care alone. The primary outcome was eczema severity on EASI, scored by nurses blinded to allocation at baseline, 2, 4 and 6 months. Skin infections were the main safety outcome, and cost-effectiveness was assessed from an NHS perspective. EASI [defines] CLOTHES Trial

Result. Geometric mean EASI went from 9.2 to 5.4 with silk and from 8.4 to 5.4 with standard care. There was no difference between groups (adjusted ratio of geometric means 0.95, 95% CI 0.85–1.07; p = 0.43), equivalent to −1.5 to +0.5 EASI points, which is not clinically important. Skin infections were similar (25% vs 28%). Even if the small observed effect were real, silk would cost £56,811 per quality-adjusted life year, above accepted NHS thresholds. The authors concluded that silk is “unlikely to provide additional benefit over standard care”. CLOTHES Trial [contradicts] Clothing and Fabrics

Limitations. Families knew their allocation, so only the nurse outcome was blinded. The authors note that using an objective primary outcome, while reducing bias, may have underestimated benefits families notice. Garments were worn on a median 81% of nights but only 34% of days, so daytime exposure was limited. A nested qualitative study found that “the hoped-for ‘miracle cure’ did not transpire”. CLOTHES Trial [relates] Parent Experiences

What it means for toddlers. Parents do not need to buy expensive therapeutic silk for a 1–4-year-old. Soft, breathable cotton next to the skin, avoiding wool and scratchy synthetics, remains the practical advice (Clothing and Fabrics). Silk garments are safe, with no excess infections, so families who find them comfortable can use them, but they should not replace emollients and anti-inflammatory treatment. National Eczema Society advice that silk can be a good option reflects comfort rather than trial evidence (see conflict in Clothing and Fabrics). CLOTHES Trial [relates] Emollient Therapy

Connections

• Clothing and Fabrics — RCT showing silk garments no benefit, source: Thomas, PLoS Med 2017
• EASI — blinded primary outcome, source: Thomas 2017
• Atopic Dermatitis — moderate to severe childhood eczema population, source: Thomas 2017
• Cost of Eczema Care — £56,811/QALY, not cost-effective, source: Thomas 2017