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Randomised controlled trial of daily emollient during infancy for preventing eczema

Research output: Contribution to journalArticle

  • Joanne R Chalmers
  • Rachel H Haines
  • Lucy E Bradshaw
  • Alan A Montgomery
  • Kim S. Thomas
  • Sara J Brown
  • Matthew J Riddhttp://orcid.org/0000-0002-7954-8823
  • Sandra Lawton
  • Eric L Simpson
  • Michael J Cork
  • Tracy H Sach
  • Carsten Flohr
  • Eleanor J Mitchell
  • Richard Swinden
  • Stella Tarr
  • Susan Davies-Jones
  • Nicola Jay
  • Maeve Kelleher
  • Michael R Perkin
  • Robert J Boyle
  • Hywel C Williams
Original languageEnglish
JournalThe Lancet
DateAccepted/In press - 21 Nov 2019

Abstract

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

Methods
We conducted a UK, multicentre, pragmatic, 2-arm, parallel-group randomised controlled trial. Term newborns with family history of atopic disease were randomised (1:1) to apply emollient daily (Diprobase cream® or DoubleBase® gel®) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (controls). Research nurses assessing outcomes at 2-years were masked to allocation. Primary outcome was eczema at 2 years (UK working party criteria) with analysis as randomised regardless of adherence to allocation and adjusting for stratification variables. Trial registration: ISRCTN21528841.

Findings
1394 newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months in those with complete data. At 2 years, eczema was present in 139/598 (23%) children in the emollient group and 150/612 (25%) in controls, adjusted relative risk 0·95, 95% CI 0·78 to 1·16, p=0·61 and adjusted risk difference -1·2%, 95% CI -5·9% to 3·6%. Other eczema definitions supported 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 (SD 0·46) in controls; 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.

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  • Full-text PDF (accepted author manuscript)

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    Licence: CC BY-NC-ND

  • Supplementary information PDF

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    Licence: CC BY-NC-ND

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