Title: Best Emollient for Eczema (BEE): Pragmatic, primary care, multi-centre, individually randomised superiority trial of four emollients in children with eczema, with internal pilot and nested qualitative study
Funder: Department of Health and Social Care

Abstract: DESIGN: Pragmatic, parallel, individually randomised superiority trial of four emollients with internal pilot and nested qualitative study SETTING: Primary care (GP surgeries) in England (East Midlands, Wessex and West of England) POPULATION: Children 6 months to 12 years old with eczema (POEM>2); willing to be randomised to and use allocated emollient as sole leave on treatment for 16 weeks; no known sensitivity to study emollient; carer able to give consent and complete outcome measures HEALTH TECHNOLOGIES: Aveeno® lotion, Diprobase® cream, Doublebase® gel, Epaderm® ointment OUTCOMES: Primary: carer-reported eczema symptoms (POEM, measured weekly for 16 weeks). Secondary: eczema signs (EASI, by blinded assessor), quality of life (condition-specific – ADQoL, generic – CHU-9D main carer and EQ-5D-5L; and Dermatitis Family Impact, DFI), use of study emollient/other eczema treatments, satisfaction with emollient and adverse effects. Data collected via online or paper questionnaires and GP electronic medical record (EMR) review at 12 months. ANALYSIS: Linear mixed models for differences in weekly POEM scores, adjusting for baseline values. SAMPLE SIZE: 520 (130 per group) to detect a difference of 3.0 in POEM scores between any two groups (b=0.90) assuming POEM SD 5.5 and 20% loss to follow-up. To account for multiple testing, a=0.0083 (a=0.05/6 pairwise comparisons equivalent). QUALITATIVE STUDY: Semi-structured interviews. Initial round with ~20 participants (including participants who stop using emollient), within first 4 weeks, with focus on emollient acceptability and perceived effectiveness. Further interviews with ~40 participants after 16 weeks will focus on experiences of emollient use and decision making around future use. Thematic analysis using constant comparative method. Audio-recording of ~60 recruitment consultations during internal pilot, to ensure robust consent procedures. CURRENT & PLANNED CARE PATHWAYS: All participants will use allocated study emollient as only leave on treatment for 16 weeks. Participants can change after this – maximising recruitment/retention but allowing collection of data on behaviour relating to preferences. PROJECT TIMETABLE: Months -6 to 0 - set-up & approvals; 1 to 6 - staff recruitment & training; participant recruitment and interviews (5 to 24); participant follow-up (9 to 28); 17 to 36 - EMR review; 28 to 40 - data cleaning, analysis & reporting. Based on feasibility study: 3 centres, ~7 participants recruited (and followed-up) per month per centre from 75 practices. Internal pilot (first 9 months of recruitment) with clear stop/go criteria based on recruitment & retention. TEAM EXPERTISE: Experienced team with established working relationships, comprising: clinical academics (primary care and dermatology); primary care researchers; trialists; medical statistician; health economist; qualitative researchers; PPI and knowledge mobilisation members.

Lay abstract: AIM: To provide better information about emollients (moisturisers) to health care professionals (HCPs) and parents/carers who look after children with eczema. BACKGROUND: 1 in 5 children in the UK have eczema, a lived-with skin condition that causes dry and itchy skin. It significantly affects both the child and their family - interfering with sleep, social activities and emotional well-being. Most children are diagnosed and looked after by their family doctor (GP) with emollients to relieve skin dryness and steroid creams (e.g. hydrocortisone) for “flares”. However, there are many different emollients and hardly any research comparing them. As a result, HCPs are unsure what to recommend and prescribing varies from one person to another. This is confusing and frustrating for parents - they often try several emollients before they find one that works for them. It also wastes everyone’s time and money. Patients, carers and HCPs agree that research is needed. DESIGN & METHODS: We want to do a “fair test” (randomised clinical trial) of the four most commonly used types of emollients (Aveeno® lotion, Diprobase® cream, Doublebase® gel and Epaderm® ointment). We are an experienced group of researchers with a good track record of doing high-quality research in this area. We have shown in a feasibility study that parents/children are willing to take part in this type of research and that we can collect the data we need. 520 children will be recruited via their GP surgery and given by chance one of four emollients to use for 16 weeks. To assess long-term effects, we will follow everyone up for 12 months. Our main question of which emollient is best will be answered by getting parents to regularly record eczema symptoms, using a measured called POEM. We will also independently assess eczema severity and collect information on: the impact of the condition on the family; quality of life of the child and the main carer; satisfaction with the emollient; and costs to the NHS and family. We will do this by parent-completed questionnaires and examining medical records. To understand emollient use better, for example any trade-offs people make between effectiveness and acceptability, we will interview a sample of families. Public & Patient Involvement: Carers in our feasibility study were enthusiastic about this work. Building on this, we have used the internet (online survey of parents and children, Twitter & Facebook) and discussed ideas with groups of parents. These activities strongly influenced: the research question; which emollients to compare; and how we should judge “effectiveness”. PPI groups will continue to contribute to the design and delivery of the funded trial. We have a parent of children with eczema as a co-applicant who is committed to representing parent views at study meetings. Dissemination: We will ensure that everyone who needs to know the findings (such as commissioners, HCPs and self-help groups) will be aware about the study from the start. A study website, researcher blogs and newsletters will be used to share study progress and generate interest. When we finish, as well as the usual academic publications and conference presentations, we will produce targeted summaries for non-academic audiences and send press releases to the media. To maximise accessibility, we will also create animations and videos for sharing via the study website and social media.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: SKIN