The randomised controlled trials, published in The Lancet, found no evidence that daily emollient use in either a population-based or high-risk cohort of infants during the first year of life can delay, suppress, or prevent atopic dermatitis.
'Emollients should not be recommended for the primary prevention of atopic dermatitis in infants,' said experts commenting on the 'unexpected' findings.
The BEEP trial took place in 12 hospitals and 4 primary care sites in the UK. Researchers enrolled term newborns with a family history of atopic disease, who were randomly assigned to application of emollient daily (Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice, or standard skin-care advice only.
In total, 1394 newborns were randomised: 693 to the emollient group and 701 to the control group. After 12 months, adherence in the emollient group was 74% in those with complete questionnaire data.
At the age of 2 years, the rates of atopic dermatitis among infants with outcome data did not differ significantly between the emollient group and the control group (23% [139 of 598] vs 25% [150 of of 612]; adjusted relative risk 0.95 [95% CI 0.78–1.16], p=0.61; adjusted risk difference -1.2% [-5.9 to 3.6]).
In addition, daily emollient use seemed to increase the risk of skin infections. The mean number of skin infections per child in year 1 was 0.23 in the emollient group compared with 0.15 in the control group (adjusted incidence rate ratio 1.55 [95% CI 1.15–2.09]).
The population-based PreventADALL trial was carried out at hospitals in Norway and Sweden. Infants of women recruited antenatally were cluster-randomised at birth from 2015 to 2017 to one of four groups: controls with no specific advice on skin care who were advised to follow national infant feeding guidelines (no intervention group); skin emollients (bath oil and facial cream) from 2 weeks of age; early complementary feeding of common food allergens (peanut, cow's milk, wheat, and egg); or combined skin and food interventions. Atopic dermatitis by age 12 months was the primary outcome.
Neither skin emollients nor early complementary feeding reduced the likelihood of developing atopic dermatitis. Among the 2397 infants enrolled, atopic dermatitis was observed in 478 (8%) of 596 in the no intervention group, 64 (11%) of 575 in the skin intervention group, 58 (9%) of 642 in the food intervention group, and 31 (5%) of 583 in the combined intervention group. The risk differences for skin intervention and food intervention were 3.1% (95% CI -0.3 to 6.5) and 1.0% (-2.1 to 4.1), respectively, in favour of control.
Furthermore, the emollient and feeding protocols appeared challenging to maintain, with full protocol adherence seen in only 27% of participants in the skin intervention group and 32% in the food intervention group.
A prospective individual patient data meta-analysis is underway to provide additional evidence on any association between the use of emollients during the first year of life and reduction in atopic dermatitis, food allergy, and associated health outcomes.