Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial

Abstract

Background Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.Methods We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parentreported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for longterm follow-up is ongoing, but the trial is closed to recruitment. Findings 1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0•95 [95% CI 0•78 to 1•16], p=0•61; adjusted risk difference -1•2% [-5•9 to 3•6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0•23 (SD 0•68) in the emollient group versus 0•15 (0•46) in the control group; adjusted incidence rate ratio 1•55 (95% CI 1•15 to 2•09).Interpretation We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

“…Both studies showed no significant reduction in the incidence of AD, and in the BEEP study, there was an increased rate of infections and a trend toward increased food allergy in the intervention group. 113,114 Similarly, an RCT by Dissanayake et al compared the incidence of AD and FA in the first year of life in infants treated with synbiotics and an emollient (alone or in combination) and controls and found no statistical difference. 163 The negative findings in these studies were surprising given the pilot study findings, and the authors discussed various reasons as to why this might have occurred including low adherence rate with the intervention (especially PreventADALL), contamination of the control arm (BEEP), and the type of emollient used.…”

“…• 2020: Two large preventative emollient RCTs using petrolatum-based creams/bath oils show no significant effect on the prevention of AD (BEEP 113 and PreventADALL 114 ) or FA (BEEP). 113 reduce the duration and severity of AD could prevent the development of FA, by either preventing epicutaneous sensitization or by increasing the window of opportunity to induce oral tolerance by early allergenic food introduction. However, results from two large RCTs using preventative emollient therapy have had initial negative results for the prevention of AD (BEEP 113 and PreventADALL 114 ) and FA (BEEP) 113 and other RCTs are ongoing (CASCADE-A Community-based Assessment of Skin Care, Allergies, and Eczema, and PEBBLES) ( Tables 1 and 2).…”

Effective Prevention of Atopic Dermatitis by Applying Fam’s Baby Moisturizer Twice Daily or Once Daily Compared with 2e Moisturizer Once Daily in High-Risk Neonates: Study Protocol for A Randomized, Blinded, Parallel, Three Group, Phase II Trial (PAF Study)

“…As mentioned above, two RCTs provided evidence that protecting the skin barrier with a moisturizer applied at the beginning of the neonatal period prevented development of infantile AD [9,10]. However, prevention of AD was not proven in the BEEP study [11] in high-risk neonates in the UK and in the PreventADALL study [12] in general populations of Norway and Sweden. Once daily moisturizer was proposed in the study protocols of these two previous studies [11,12].…”

“…However, prevention of AD was not proven in the BEEP study [11] in high-risk neonates in the UK and in the PreventADALL study [12] in general populations of Norway and Sweden. Once daily moisturizer was proposed in the study protocols of these two previous studies [11,12]. Reasons for the inconsistency in results for moisturizer interventions might be due to different countries and cultures, different types of moisturizers, and differences in adherence.…”

“…Another pilot RCT, which was conducted in the United Kingdom and the United States, showed that applying moisturizer after birth was effective in primary prevention of AD (relative risk: 0•50, 95% CI: 0.28-0.90) [10]. Recently, the BEEP study showed that application of the moisturizer Doublebase Gel (Dermal Laboratories, Herts, UK) or Diprobase Cream (Bayer, Berks, UK), at least once daily from early birth had no preventive effect on AD (adjusted relative risk: 0.95 95% CI: 0.78-1.16, p=0.61) [11]. Similarly, the PreventADALL study (2×2 factorial design), which tested two primary prevention strategies of skin care and early food introduction, showed that an oil bath and application of a moisturizer to the infant's face (Ceridal cream) at least 5 days per week from 0.5 to 9 months of age was not effective in preventing AD [12].…”