Overview

This randomised controlled trial tested whether emollient use in the first year of life in infants at high risk of eczema could prevent the disease, and other atopic disorders including food allergy.1 It involved 1394 newborns recruited at 12 UK hospitals and primary care sites. Infants were randomly assigned to receive emollient (a choice of Diprobase cream or Doublebase gel) with best practice skincare advice or best practice skincare advice alone. Skincare advice (delivered via a booklet and a video) recommended using mild cleansers formulated for infants and to avoid soap, bubble bath and baby wipes. In the emollient group, parents were advised to apply emollient to the whole body (except scalp) at least once a day and after every bath or shower. Parents were advised to stop applying the emollient when their child reached its first birthday. No prompts or reminders were sent to parents, to reflect how the intervention would be delivered in normal practice.

The primary outcome was diagnosis of eczema in the past 12 months assessed when the infants reached 2 years of age.1 Evaluation of the primary outcome was carried out by research nurses masked to treatment allocation. The follow-up period was chosen to ensure that the emollient had a lasting protective effect rather than masking any mild eczema that might occur during the treatment period. Infants were also tested for food allergies and genotyped for four common mutations in the filaggrin gene associated with eczema.1 2 At the end of follow-up, there was no significant difference in eczema incidence between the two treatment arms.1 Eczema was present in 139 (23%) of 598 infants in the emollient group and 250 (25%) of 612 infants in the control group (adjusted risk ratio 0.95, 95% CI 0.78 to 1.16; p=0.61; adjusted risk difference −1.2%. 95% CI −5.9 to 3.6).

Adherence to the treatment was high in those who provided complete questionnaire data at each time point: 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months and 74% (375 of 506) at 12 months.1 Assuming that 100% of those who did not provide data at these time points did not apply the emollient, the proportion of families classed as having satisfactory adherence was 51%. On the days that emollients were used, most families chose to apply the emollient once a day, usually after a bath or shower. Washing practices were balanced across groups. There were no statistically significant differences in food allergies between the groups, with 41 of 547 infants (7%) in the emollient group and 29 of 568 (5%) in the control group confirmed as allergic to milk, egg or peanut. There was no difference between groups in other types of allergy, and no differences in quality of life measures for infants or their parents.

(Funding was provided by the UK National Institute for Health Research, Goldman Sachs Gives, and the Sheffield Children’s Hospital Research Fund. Various authors declared funding received from pharmaceutical and other commercial companies outside the submitted work.)

Context

This large pragmatic study was designed after two small randomised pilots provided evidence suggesting regular emollient use in the first year of life could prevent eczema.1 The results of this larger study do not support such an approach and are in agreement with another large trial of the effect of emollient treatment and early complementary feeding in 2397 newborn infants. The other large study, conducted in Sweden, assessed the effect of skin emollients, early complementary feeding (peanut, cow’s milk, wheat and egg), combined skin and food interventions or no intervention on atopic dermatitis assessed at 12 months.3 At 12 months, neither the skin intervention nor the food intervention reduced development of atopic dermatitis compared with the control group. The results of these two large studies suggest that emollients should not be used for the primary prevention of atopic dermatitis in infants.4