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

Chalmers, Joanne R.; Haines, Rachel H.; Bradshaw, Lucy E.; Montgomery, Alan A.; Thomas, Kim S.; Brown, Sara J.; Ridd, Matthew J.; Lawton, Sandra; Simpson, Eric L.; Cork, Michael J.; Sach, Tracey H.; Flohr, Carsten; Mitchell, Eleanor J.; Swinden, Richard; Tarr, Stella; Davies-Jones, Susan; Jay, Nicola; Kelleher, Maeve; Perkin, Michael R.; Boyle, Robert J.; Williams, Hywel C.

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Joanne R. Chalmers

Rachel H. Haines

Director Nottingham Clinical Trials Unit

Sara J. Brown

Matthew J. Ridd

Sandra Lawton

Eric L. Simpson

Michael J. Cork

Tracey H. Sach

Carsten Flohr

Richard Swinden

Stella Tarr

Susan Davies-Jones

Nicola Jay

Maeve Kelleher

Michael R. Perkin

Robert J. Boyle

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Professor of Dermato-Epidemiology



Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.


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 parent-reported 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 long-term follow-up is ongoing, but the trial is closed to recruitment.


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).


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.


Chalmers, J. R., Haines, R. H., Bradshaw, L. E., Montgomery, A. A., Thomas, K. S., Brown, S. J., …Williams, H. C. (2020). Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet, 395(10228), 962-972.

Journal Article Type Article
Acceptance Date Nov 21, 2019
Online Publication Date Feb 19, 2020
Publication Date Mar 21, 2020
Deposit Date Jan 15, 2020
Publicly Available Date Mar 2, 2020
Journal Lancet
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 395
Issue 10228
Pages 962-972
Public URL
Publisher URL


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