A multicentre randomized controlled trial of ion-exchange water softeners for the treatment of eczema in children: protocol for the Softened Water Eczema Trial (SWET) (ISRCTN: 71423189)

Thomas, K. S. and Sach, T. H. ORCID: https://orcid.org/0000-0002-8098-9220 and on behalf of the SWET Trial Investigators (2008) A multicentre randomized controlled trial of ion-exchange water softeners for the treatment of eczema in children: protocol for the Softened Water Eczema Trial (SWET) (ISRCTN: 71423189). British Journal of Dermatology, 159 (3). pp. 561-566. ISSN 1365-2133

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Abstract

Background: There is epidemiological evidence linking increased water hardness with increased eczema prevalence. A number of plausible mechanisms can be forwarded to suggest why hard water could exacerbate eczema. The most likely explanation is increased soap usage in hard water areas, the deposits of which can cause skin irritation in individuals with eczema. Objectives: To assess the cost and cost‐effectiveness of ion‐exchange water softeners for the treatment of eczema in children. Patients/Methods: Three hundred and ten children aged 6 months to 16 years, with moderate to severe eczema. The children must live in hard water areas (≥ 200 mg L−1 of calcium carbonate) and have a home that is suitable for the installation of a water softener. This is a single‐blind, parallel‐group, randomized controlled trial of 12 weeks duration followed by a 4‐week cross‐over period. Results/Analysis Plan: Primary outcome: difference in the mean change in disease severity (Six Area, Six Sign Atopic Dermatitis score) at 12 weeks compared with baseline. Secondary outcomes: (i) proportion of time spent moving during the night; (ii) self‐reported global changes in eczema severity; (iii) amount of topical treatment used; (iv) Patient Oriented Eczema Measure; (v) number of totally controlled and well controlled weeks; (vi) impact on health‐related quality of life for the child (EQ‐5D) and the family (Dermatitis Family Impact questionnaire); and (vii) cost‐effectiveness. It is planned that recruitment will be completed by the end of 2008 and results will be available towards the end of 2009.

Item Type: Article
Faculty \ School: Faculty of Science > School of Pharmacy (former - to 2024)
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Health Economics
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Depositing User: EPrints Services
Date Deposited: 25 Nov 2010 11:13
Last Modified: 24 Sep 2024 09:35
URI: https://ueaeprints.uea.ac.uk/id/eprint/15242
DOI: 10.1111/j.1365-2133.2008.08704.x

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