Emolientes en prevención de la DA

Published in Dermatology and 

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Journal Scan / Research · March 11, 2020

Daily Emollient During Infancy for Prevention of Eczema

The Lancet

TAKE-HOME MESSAGE

• Researchers of this multicenter study recruited full-term infants who were at high risk for developing eczema (having a first-degree relative with eczema, allergic rhinitis, or asthma) and randomized them to an emollient (n=693) or control (n=701) group. Caregivers of both groups received standard skin-care advice, and those in the treatment group were provided with an emollient consisting of Diprobase Cream or Doublebase Gel by the research team. Among patients with complete data at 2 years of age, eczema was seen in 139 of 598 patients (23%) in the emollient group and 150 of 612 patients (25%) in the control group. The adjusted incidence rate ratio of skin infection was 1.55 in the emollient group compared with controls.

• There was no evidence that daily emollient therapy during the first year of life prevented, delayed, or suppressed the development of eczema by age 2 years among high-risk children.

– Caroline K. Crabtree, MD

Written by

 

 

Sarah L Chamlin MD

This study, the BEEP trial, randomized 1394 infants at high risk of developing atopic dermatitis (AD) to either daily emollient use or standard care. This large study was an attempt to definitively prove the benefit of early emollients in the prevention of AD. Two previous and promising studies showed evidence that AD prevention in this manner was possible. Unfortunately, this trial reports no difference in the groups for the presence of AD, severity of AD, or time to AD onset. Moreover, the mean number of skin infections was increased in the emollient group with an adjusted incidence ratio of 1.55 (95% CI, 1.15–2.09), another surprising result.

Because eczema usually precedes the development of food allergy and other atopic diseases, many also hypothesize that preventing AD with emollient use may also prevent food allergies by decreasing food antigen exposure through the skin. Of note, there was no evidence that emollients reduced the risk of food allergy.

These unexpected results are very disappointing. Many of us who care for children with AD have been suggesting emollient use for new siblings based on the previous positive studies. While it may be awkward or difficult to change this recommendation, this well-designed study does not support this practice.

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 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.

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.

The Lancet

Daily Emollient During Infancy for Prevention of Eczema: The BEEP Randomised Controlled Trial

Lancet 2020 Feb 19;[EPub Ahead of Print], JR Chalmers, RH Haines, LE Bradshaw, AA Montgomery, KS Thomas, SJ Brown, MJ Ridd, S Lawton, EL Simpson, MJ Cork, TH Sach, C Flohr, EJ Mitchell, R Swinden, S Tarr, S Davies-Jones, N Jay, MM Kelleher, MR Perkin, RJ Boyle, HC Williams