Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial

Abstract

BackgroundAtopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis).MethodsThis is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires.DiscussionThis trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases.Trial registrationISRCTN registry; ID: ISRCTN21528841. Registered on 25 July 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2031-3) contains supplementary material, which is available to authorized users.

Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance

“…Regular use of emollients is the mainstay of AD treatment and can potentially prevent flares. [27][28][29][30][31][32] Preliminary data from a cohort study has shown a potential primary prevention interest for emollients, 33 however the results from a larger cohort in two studies did not confirm this hypothesis (European Academy of Allergy and Clinical Immunology (EAACI) 2019 Congress: Session HT 2 (Boyle) and abstract TP0986 (Skjerven). Presented June 2 and 3, 2019).…”

An algorithm for diagnosing IgE‐mediated food allergy in study participants who do not undergo food challenge

“…The BEEP study is a pragmatic, parallel-group, multi-centre, assessor-blind, randomized-controlled trial, details of which have been described elsewhere. 7 In brief, the BEEP study randomized 1395 participants between November 2014 and November 2016, recruited from 16 study centres across England. Participants were born at ≥37-week gestation and had a first-degree relative with parent-reported eczema, asthma or allergic rhinitis diagnosis.…”

“…The Barrier Enhancement for Eczema Prevention (BEEP) study is a pragmatic, multi‐centre, randomized‐controlled trial of daily emollient use for the first year of life for primary prevention of eczema, in infants with a family history of atopic disease (ISRCTN21528841). Evaluation of IgE‐mediated food allergy was added to the initial study protocol after recruitment had commenced, but before any 2‐year follow‐up visits were conducted, once separate funding was secured . It was anticipated that a significant number of participants might decline to attend for OFC in BEEP, as the food allergy testing was presented to parents at the 2‐year visit as an optional sub‐study in a pragmatic, low‐contact trial with eczema prevention as its initial focus.…”

“…Evaluation of IgE-mediated food allergy was added to the initial study protocol after recruitment had commenced, but before any 2-year follow-up visits were conducted, once separate funding was secured. 7 It was anticipated that a significant number of participants might decline to attend for OFC in BEEP, as the food allergy testing was presented to parents at the 2-year visit as an optional sub-study in a pragmatic, low-contact trial with eczema prevention as its initial focus. Furthermore, the BEEP trial was a multi-centre trial run across a wide geographical area and study OFCs were limited to two UK centres, Sheffield and London (See map of geographical distribution of recruited individuals in Supinfo 2).…”

Personalized medicine—concepts, technologies, and applications in inflammatory skin diseases

“…Alternatively, and perhaps more feasibly, WGS of the newborn can provide the same information, albeit a little later. In case mutations in skin barrier genes (like FLG) are detected, early intervention schemes can be applied, such as use of emollients soon after birth (205). In best case, such a personalized preventive strategy may hinder development of AD and its comorbidities (the atopic march) altogether.…”