A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Trials
Eleanor F HarrisonKim S Thomas

Abstract

Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and...Continue Reading

References

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Oct 6, 2014·The Journal of Allergy and Clinical Immunology·Jochen SchmittUNKNOWN HOME initiative collaborators
Apr 19, 2015·BMC Dermatology·Helen NankervisKim S Thomas

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Citations

Apr 21, 2017·Journal of the European Academy of Dermatology and Venereology : JEADV·F SampognaUNKNOWN European Academy of Dermatology and Venereology TaskForce on Quality of Life
May 1, 2017·The Journal of Allergy and Clinical Immunology·Sinéad M LanganKim S Thomas
Mar 22, 2019·Journal of the European Academy of Dermatology and Venereology : JEADV·K S Thomas, UNKNOWN CLOTHES Trial Team
Nov 23, 2021·Journal of Tissue Engineering and Regenerative Medicine·Mohammad Hossein KhosropanahMasoumeh Majidi Zolbin

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Software Mentioned

MLwiN
SE
Stata
CLOTHES

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