A randomized, decentralized clinical trial has shown that applying a daily moisturizer beginning in early infancy may lower the risk of developing atopic dermatitis, commonly known as eczema, by age 2 years.
The study enrolled 1,247 infant–parent dyads from 25 community-based pediatric and family medicine clinics in Colorado, North Carolina, Oregon, and Wisconsin. Participants were randomized to receive either once-daily full-body emollient application or standard skin care. The intervention began by 9 weeks of age and continued until 24 months. Families were mailed one of five dermatologist-reviewed bland emollients every 6 months and were instructed to apply it to the entire body, excluding the scalp and diaper area if preferred. Emollients included formulations with and without ceramides; adherence was high, with over 50% of participants in the intervention arm reporting seven applications per week throughout the study period.
By 24 months, the cumulative incidence of physician-diagnosed atopic dermatitis (AD), as recorded in the child’s medical record, was 36.1% (SE, 2.1%) in the moisturizer group and 43.0% (SE, 2.1%) in the control group. This corresponded to a relative risk (RR) of 0.84 (95% CI, 0.73–0.97; P = .02) and a number needed to treat of 15.
Subgroup analyses explored whether family history of allergic disease influenced the intervention's effectiveness. Among 629 infants without a first-degree relative with AD, asthma, or hay fever, the incidence of AD was 33.2% (SE, 2.9%) in the moisturizer group versus 43.4% (SE, 2.9%) in the control group. The corresponding RR was 0.75 (95% CI, 0.60–0.90; P = .01), with a risk difference of −10.1% (95% CI, −18.1% to −2.2%). Among 599 infants with a family history of atopic disease, AD incidence was 39.1% (SE, 2.9%) in the moisturizer group compared with 42.5% (SE, 3.1%) in the control group; this difference was not statistically significant.
Dog ownership further modified outcomes. In households with dogs, infants in the moisturizer group had a 27.5% (SE, 4.7%) incidence of AD, compared with 42.9% (SE, 3.5%) in the control group. This represented a risk difference of −14.2% (95% CI, −23.2% to −4.6%) and a RR of 0.68 (95% CI, 0.50–0.90; P = .01). Cat ownership did not significantly influence outcomes.
Safety outcomes were also assessed. Rash was the most frequently reported adverse event in both groups, though most cases were mild or moderate. No treatment-related severe adverse events were reported. Skin infection rates were 19.8% in the moisturizer group and 21.1% in the control group (RR, 0.94; 95% CI, 0.74–1.20). Food allergy was reported in 10.7% of the moisturizer group versus 14.2% of the control group (RR, 0.76; 95% CI, 0.55–1.04); these differences were not statistically significant.
These findings suggest that daily application of a bland emollient beginning in early infancy may represent a feasible, low-risk strategy to reduce the incidence of atopic dermatitis, particularly in infants without a strong genetic predisposition or in households with dogs.
Full disclosures and funding information are available in the published study.
Source: JAMA Dermatology
