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

To investigate whether daily use of emollient in the first year of life prevents development of eczema at 2 years of age in children at high risk.

1394 high-risk newborns in the UK. High-risk is defined by presence of a first-degree relative with eczema, allergic rhinitis, or asthma.

Infants were randomly assigned to the control group (standard skin-care advice only) or emollient group (additionally advised to apply emollient at least once daily and after every bath for the first year of life). Interim follow-up at 2 weeks, 3, 6, 12, and 18 months (questionnaire), and at 2 years via a follow-up visit with a trained research nurse (masked to treatment allocation). Primary outcome was eczema at 2 years as defined by UK working party criteria, and results analyzed by intention-to-treat.

Eczema was present in 23% (139) of 598 infants in the emollient group compared with 15% (150) of 612 infants in the control group (adjusted relative risk 0.95, 95% CI 0.78 to 1.16, P = .61). Adherence in the emollient group ranged from 88% to 74% at 3 and 12 months, respectively. Mean number of skin infections per child during the treatment period in the first year of life was 0.23 (SD 0.68) in the emollient group versus 0.15 (SD: 0.46) in the control group (adjusted incidence rate ratio: 1.55, 95% CI 1.15 to 2.09). Food allergy occurred more frequently in the emollient group (7%) than the control group (5%) (adjusted relative risk 1.47, 95% CI 0.93–2.33).

This study did not find sufficient evidence to support the use of daily emollient during the first year of life prevents the development of eczema at 2 years in children at high risk. There was some evidence to suggest an increased risk of skin infections and possibly more food allergy in the intervention group.

Prior observations from pilot studies have supported the rationale for initiation of emollient application in early infancy to prevent the development of atopic dermatitis; therefore, the results of this study were unexpected. Factors from the BEEP trial that may have confounded their outcomes include the following: (1) insufficient quantities of emollient may have been applied, (2) intervention for longer than a year might be required, and (3) emollients may need to be applied multiple times per day to be protective (72% to 79% applied daily, only 17% to 20% applied twice daily). In addition, although the study was designed to reflect application in normal practice with an affordable, easily available emollient, a more complex emollient formulation such as one containing ceramides and pH modulators, may have a protective effect. An ongoing trial (PEBBLES) using a ceramide-based emollient applied twice daily may provide additional insight into whether a nuanced approach to skin care is more effective in preventing the development of atopic dermatitis and food allergen sensitization.