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. 2025 Jul 23:e252357.
doi: 10.1001/jamadermatol.2025.2357. Online ahead of print.

Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial

Eric L Simpson  1 , LeAnn C Michaels  2 , Katrina Ramsey  3 , Lyle J Fagnan  4 , Donald E Nease  5 , Mary Henningfield  6 , Rowena J Dolor  7 , Jodi Lapidus  3 , Xaviera Martinez-Ziegenfuss  4 , Annette Vu  2 , Laura Ferrara  4 , Katharine E Zuckerman  8 , Cynthia D Morris  2 , Hywel C Williams  9 ; CASCADE Consortium
Affiliations

Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial

Eric L Simpson et al. JAMA Dermatol. .

Abstract

Importance: Atopic dermatitis (AD) imposes a global health burden for children and is a risk factor for developing food allergy and asthma. Few studies have evaluated emollient intervention for primary AD prevention in infants not selected for risk.

Objective: To determine whether emollient intervention in infants not selected for risk reduces AD incidence by age 24 months.

Design, setting, and participants: A randomized, decentralized pragmatic clinical trial was conducted that involving 1247 infant-parent dyads recruited from 25 community-based pediatric and family medicine clinics that are members of 4 statewide practice-based research networks. Participants were recruited from July 2018 to February 2021, with follow-up completed through February 2023.

Intervention: Dyads were randomized to 1 of 2 groups: a daily full-body emollient application daily moisturizer group starting by age 9 weeks or a control group that refrained from emollient use.

Main outcomes and measures: The primary outcome was physician-diagnosed AD recorded in the patient's medical record by age 24 months. Participants completed quarterly electronic surveys to report adverse events and alert the team if an AD diagnosis had been made. Trained research coordinators abstracted participants' medical records.

Results: Of 1247 infants, 553 (44.3%) were female, and the mean (SD) age at randomization was 23.9 (16.3) days. At 24 months, the cumulative incidence of AD was 36.1% (SE, 2.1) in the daily moisturizer group and 43.0% (SE 2.1) in the control group, with a relative risk (RR) of 0.84 (95% CI, 0.73-0.97; P = .02), and the magnitude of effect was larger in the population not at high risk of AD (RR, 0.75; 95% CI, 0.60-0.90; P = .01). The protective effect was significantly modified by the presence of a dog in the home (RR, 0.68; 95% CI, 0.50-0.90; P = .01). There were no between-group differences in cutaneous adverse events.

Conclusions and relevance: This randomized clinical trial found that daily emollient application beginning before age 9 weeks in a representative US population not selected for risk reduced the cumulative incidence of AD at age 24 months. Implementing this approach to pediatric skin care may be a feasible way to reduce the burden of AD in US communities.

Trial registration: ClinicalTrials.gov Identifier: NCT03409367.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Simpson reported grants from National Institute of Arthritis and Musculoskeletal and Skin Diseases during the conduct of the study as well as personal fees from AbbVie, Aclaris Therapeutics, Amgen, Arcutis, Areteia Therapeutics, Astria Therapeutics, Attovia Therapeutics, Inc, Bambusa Therapeutics Inc, Bristol Myers Squibb, Castle, CorEvitas, Corvus, Dermira, Eli Lilly, Evelo Biosciences, Evomunne, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Gilead Sciences, Impetus Healthcare, Incyte, Innovaderm Reche, Inmagene Biopharmaceuticals, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LectureLinx (LLX), Leo, Merck, NUMAB Therapeutics AG, Pfizer, Physicians World LLC, PRImE, Recludix Pharma, Regeneron, Roche Products Ltd, Roivant, Sanofi-Genzyme, SITRYX Therapeutics, Trevi therapeutics, and Valeant; grants from AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Castle, CorEvitas, Dermavant, Dermira, Incyte, Lilly, Pfizer, Regeneron, Sanofi, Target, and VeriSkin; and being a subinvestigator for AbbVie, Allakos, Amgen, Arcutis, Aslan, BMS, Dermavant, DermBiont, Eli Lilly, Galderma, Hallux, Incyte, Leo, Moberg, Technoderma, and UCB outside the submitted work. Drs Michaels, Nease, Dolor, Lapidus, Martinez-Ziegenfuss, and Ramsey reported grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases during the conduct of the study and 3 companies donated emollients to the trial outside the submitted work, including L'Oreal USA, Galderma Laboratories, LP, and Pharmaceutical Specialties, Inc. Dr Morris reported grants from the National Institutes of Health during the conduct of the study as well as grants from the National Institutes of Health outside the submitted work. Dr Williams reported being the chief investigator of the BEEP trial, a UK government-funded trial of 1394 infants at high risk of developing eczema, outside of the submitted work. No other disclosures were reported.

Comment in

  • doi: 10.1001/jamadermatol.2025.2354

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