Highlight
- Daily application of a full-body emollient from early infancy reduces the incidence of physician-diagnosed atopic dermatitis (AD) by age 24 months in a general population of infants.
- The protective effect is more pronounced in infants not considered at high risk for AD, highlighting potential broad applicability.
- Living with a dog appears to enhance the emollient’s protective effect on reducing AD risk.
- Emollient use did not increase cutaneous adverse events, supporting safety in routine pediatric skin care.
Study Background and Disease Burden
Atopic dermatitis (AD), commonly referred to as pediatric eczema, represents a significant global health burden, affecting up to 20% of children worldwide. Beyond the distressing cutaneous symptoms, AD is integrally linked to an “atopic march,” a progression that often includes food allergies, asthma, and allergic rhinitis. Early interventions to prevent AD, particularly primary prevention targeting infants before disease onset, remain a priority in pediatric and dermatological care. Although emollient therapy is a cornerstone of AD management to restore skin barrier function, few rigorous studies have explored its preventive role in infants not preselected for elevated AD risk. The current trial addresses this gap by assessing whether a simple, daily emollient intervention started before 9 weeks of age can reduce AD incidence in a heterogeneous, community-based infant population.
Study Design
This pragmatic, randomized, decentralized clinical trial enrolled 1,247 infant-parent dyads from 25 community pediatric and family medicine clinics across four statewide practice-based research networks in the United States. Participants were recruited between July 2018 and February 2021, with follow-up through February 2023.
Eligibility criteria were broad, enabling inclusion of infants representative of the general population, without selection for familial AD risk factors. Participants were randomly assigned (1:1) to either the intervention arm, involving daily full-body application of a moisturizer emollient starting by age 9 weeks, or to a control arm instructed to refrain from emollient use.
Primary outcome was physician-recorded diagnosis of AD within the first 24 months of life, abstracted from medical records by trained coordinators. Secondary monitoring included quarterly electronic surveys that captured caregiver-reported adverse events and AD diagnoses.
Key Findings
Of the 1,247 infants randomized, 44.3% were female, with a mean age at enrollment of approximately 24 days. By 24 months, the cumulative incidence of physician-diagnosed AD was 36.1% (SE 2.1) in the emollient group compared to 43.0% (SE 2.1) in controls, yielding a relative risk (RR) reduction of 16% (RR 0.84; 95% CI 0.73–0.97, P=0.02).
Notably, subgroup analysis demonstrated the preventive effect was more pronounced in infants not at high risk for AD (RR 0.75; 95% CI 0.60–0.90, P=0.01), highlighting the intervention’s broader applicability beyond genetically predisposed populations.
An intriguing effect modifier was household exposure to dogs. Infants living with a dog experienced an enhanced protective effect of emollient use (RR 0.68; 95% CI 0.50–0.90; P=0.01), suggesting potential synergistic interactions between environmental factors and skin barrier support in early-life immune conditioning.
Safety analyses revealed no statistically significant difference in cutaneous adverse events between groups, underscoring the tolerability and safety of daily emollient use in infants.
Expert Commentary
This rigorously conducted pragmatic trial provides compelling evidence that routine early-life application of emollients can reduce the risk of developing AD in a broad infant population. It supports the concept that early restoration or preservation of skin barrier integrity may modulate the initial inflammatory pathways of AD pathogenesis, consistent with existing mechanistic insights.
The enhancement of the protective effect by living with a dog aligns with emerging literature linking early environmental exposures to immune tolerance and allergic disease prevention. However, these findings warrant further exploration to unravel underlying immunological mechanisms.
While previous studies targeted high-risk infants, this study’s inclusive design strengthens generalizability. Nevertheless, adherence to daily emollient application outside a clinical trial setting and long-term benefits beyond two years remain areas for future investigation.
Conclusion
Daily full-body emollient application beginning before 9 weeks of age significantly reduces the cumulative incidence of physician-diagnosed atopic dermatitis by age 24 months among infants in a representative US population. The intervention is safe, simple, and potentially scalable, offering a promising primary prevention strategy for pediatric eczema. Incorporation of early emollient use into standard infant care guidelines could lessen the burden of AD and its associated atopic comorbidities. Ongoing research is needed to optimize emollient formulations, understand environmental modifiers, and assess durability of protection into later childhood.
References
Simpson EL, Michaels LC, Ramsey K, et al. Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial. JAMA Dermatol. Published online July 23, 2025. doi:10.1001/jamadermatol.2025.2357
Flohr C, Yeo L. Atopic dermatitis and the atopic march. J Allergy Clin Immunol. 2019;143(1):26-44.
Miller R, Strunk RC. Influence of Early Life Skin Barrier Function and Microbiome on Allergic Sensitization. J Allergy Clin Immunol. 2020;145(3):659-669.
