Fong Wei Chern Gavin, Howells Laura, Muller Ingrid, Mitchell Eleanor J, Baker Arabella, Thuma Leila, Harrison Eleanor, Bradshaw Lucy, Jiang Yimin, Cowdel Fiona, Leighton Paul, Montgomery Alan, Ravenscroft Jane, Ridd Matthew J, Santer Miriam, Tanaka Reiko J, Hilken Nicholas, Swinden Richard, Dooley Richard, Layfield Carron, Upton Clare, Collins Sophia, Davies Firoza, Owen Tracy, Eddis-Finbow Mars, Patel Devin, Putrym Goldie, Williams Hywel C, Roberts Amanda, Thomas Kim S
Centre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UK.
Primary Care Research Centre, University of Southampton, Southampton, England, UK.
NIHR Open Res. 2025 Jan 17;4:63. doi: 10.3310/nihropenres.13659.1. eCollection 2024.
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.
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).
ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473.
一项湿疹（同义词：特应性皮炎、特应性湿疹）的优先事项设定合作项目已确定洗澡频率是患者关注的关键领域。然而，目前尚无大型、高质量的随机对照试验对此进行研究。快速湿疹试验项目是一项新颖的研究计划，旨在采用公民科学方法开展多项在线随机对照试验。该项目包括与公众成员合作，共同设计和开展研究，以解答对他们来说重要的问题。通过该项目进行的首个试验正在评估洗澡频率对湿疹的影响。
这是一项具有内部预试验阶段的在线双臂平行组优效性随机对照试验。年龄≥1岁且居住在英国的湿疹患者符合条件。排除标准为：患有其他类型湿疹的人，如静脉曲张性湿疹、手部湿疹和接触性湿疹；最近开始新的湿疹治疗；正在参加另一项湿疹试验；患者导向性湿疹量表（POEM）≤2；计划每周游泳超过两次；无法/不愿意改变洗澡习惯。参与者按1:1分配到每周洗澡组（每周洗澡1或2次）或每日洗澡组（每周洗澡6次或更多次），为期4周。主要结局指标是POEM，在4周内每周进行评估。次要结局指标包括皮肤特异性生活质量、湿疹控制情况、瘙痒严重程度、常用湿疹治疗方法的使用情况、POEM改善≥3分的参与者比例、湿疹的总体变化以及安全性结局指标。还将邀请一部分参与者参加半结构化访谈，以讨论他们的经历。主要的比较分析将根据随机分配情况进行，而不考虑实际洗澡频率。该试验将按照CONSORT指南进行报告。本研究已于2023年10月11日获得伦敦-萨里研究伦理委员会（英国伦敦E20 1JQ，Redman Place 2号）的伦理批准（批准号：23/PR/0899）。
ISRCTN12016473，2023年11月22日，https://doi.org/10.1186/ISRCTN12016473 。
