The Eczema Bathing Study: weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 2; peer review: 1 approved, 2 approved with reservations]

Abstract

Background: a priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this.

The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema.

Methods: this is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899).

Trial registration: ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473

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Identifiers

ORCID for Ingrid Muller: orcid.org/0000-0001-9341-6133

ORCID for Miriam Santer: orcid.org/0000-0001-7264-5260

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