Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial

RCT (n=2397 newborns in Norway) found that neither early skin emollients nor early complementary feeding reduced development of atopic dermatitis by age 12 months, therefore these interventions should not be used to prevent atopic dermatitis by 12 months of age in infants.

SPS commentary:

In this trial, subjects were assigned to no intervention group (no specific advice on skin care while advised to follow national guidelines on infant nutrition), skin emollients (bath additives and facial cream; skin intervention group); early complementary feeding of peanut, cow's milk, wheat, and egg (food intervention group); or combined skin and food interventions (combined intervention group.


Also published along this study in Lancet is a UK trial (BEEP; n=1394 newborns in UK), which found no evidence that daily emollient during first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections.


According to a commentary, the absence of a preventive effect on atopic dermatitis might be associated with the type, frequency of application, and timing of commencement of emollient. It notes that following promising results of a trend to reduced atopic dermatitis and food sensitisation at age 12 months from a pilot study using a ceramide-dominant emollient with a slightly acidic pH, twice daily from birth, a large RCT in high-risk infants, Prevention of Eczema by a Barrier Lipid Equilibrium Strategy (PEBBLES), is underway to confirm these findings including food allergy endpoints. It adds however that even if the results show a reduction in these atopic outcomes, lessons from thus current study suggest this intensive twice daily emollient regimen, not to mention the high cost of this complex formulation, could affect its potential viability as a population-based preventive strategy. It alludes to an ongoing prospective individual patient data meta-analysis that will provide additional evidence on any association between use of emollients during the first year of life and reduction in atopic dermatitis, food allergy, and associated health outcomes. It suggests that at this stage, emollients should not be recommended for the primary prevention of atopic dermatitis in infants.


The Lancet

Resource links:

BEEP trial