Trial results investigating the effect of daily emollient use on Atopic Dermatitis incidence were posted on ClinicalTrials.gov on 2025-08-15. The study found that daily emollient use from birth significantly reduced the risk of Atopic Dermatitis requiring prescription or over-the-counter therapies, with a risk ratio of 0.68 (p=0.0004).
Background
Atopic dermatitis (AD) is a prevalent condition, affecting over 9 million children in the U.S. It is often a precursor to other allergic conditions such as asthma and food allergy, as well as skin infections and neurodevelopmental disorders. Recent research highlights skin barrier dysfunction as a primary initiator of AD and a potential factor in allergic sensitization. This trial aimed to test the hypothesis that consistent daily emollient use from birth could prevent the development of AD in a community setting, including newborns not specifically selected for risk factors.
Trial design
This community-based clinical trial, designated as Phase NA, enrolled a total of 1260 participants. The study focused on conditions including Atopic Dermatitis, Atopic Disorders, Eczema, and Atopic Eczema. The intervention arm involved daily emollient use, while the comparator arm followed a natural skin care regimen. The trial utilized a pragmatic design to ensure its results would be broadly applicable to the general population.
Key results
The trial reported several key measurements and analyses comparing the Daily Emollient group to the Natural Skin group:
- Provider-diagnosed Atopic Dermatitis: 217.7 participants with imputed values in the Daily Emollient group versus 268.5 in the Natural Skin group. Analysis showed a Risk Ratio (RR) of 0.84 (95.0% CI: 0.73, 0.97) with a p-value of 0.019.
- Parent Report of Atopic Dermatitis: 161.1 participants with imputed values in the Daily Emollient group versus 219.1 in the Natural Skin group. Analysis showed a Risk Ratio (RR) of 0.76 (95.0% CI: 0.65, 0.9) with a p-value of 0.002.
- Atopic Dermatitis by UK Working Party Criteria: 72.3 participants with imputed values in the Daily Emollient group versus 83.1 in the Natural Skin group. Analysis showed a Risk Ratio (RR) of 0.86 (95.0% CI: 0.65, 1.15) with a p-value of 0.323.
- Atopic Dermatitis by Children's Eczema Questionnaire: 156.9 participants with imputed values in the Daily Emollient group versus 195.3 in the Natural Skin group. Analysis showed a Risk Ratio (RR) of 0.83 (95.0% CI: 0.7, 0.99) with a p-value of 0.044.
- Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart: 116.5 participants with imputed values in the Daily Emollient group versus 179.8 in the Natural Skin group. Analysis showed a Risk Ratio (RR) of 0.68 (95.0% CI: 0.55, 0.84) with a p-value of 0.0004.
- Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal): 385.3 participants with imputed values in the Daily Emollient group versus 356.5 in the Natural Skin group. Analysis showed an Odds Ratio (OR) of 0.7 (95.0% CI: 0.55, 0.89) with a p-value of 0.004.
The analyses consistently indicated a reduced risk of Atopic Dermatitis in the daily emollient group across most outcome measures, with several reaching statistical significance.
What this means
The findings suggest that implementing daily emollient use from birth can be an effective strategy to reduce the incidence of Atopic Dermatitis in newborns within a community setting. The statistically significant reductions observed across various diagnostic criteria, particularly for cases requiring therapeutic intervention, highlight the potential for this simple, accessible intervention to improve outcomes for children at risk of or developing AD. This pragmatic trial design supports the applicability of these results to the broader population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03409367, titled "A Community-based Assessment of Skin Care, Allergies, and Eczema", were posted on 2025-08-15 on clinicaltrials.gov.