JAMA Dermatology

<jats:sec><jats:title>Importance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine whether emollient intervention in infants not selected for risk reduces AD incidence by age 24 months.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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; <jats:italic>P</jats:italic> = .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; <jats:italic>P</jats:italic> = .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; <jats:italic>P</jats:italic> = .01). There were no between-group differences in cutaneous adverse events.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT03409367?term=NCT03409367&amp;amp;amp;rank=1">NCT03409367</jats:ext-link></jats:p></jats:sec>

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Assessment of atopic dermatitis using self-report and caregiver report: a multicentre validation study.

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Arch Dermatol

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12-Month prevalence of atopic dermatitis in resource-rich countries: a systematic review and meta-analysis.

Sci Rep

Do early skin care practices alter the risk of atopic dermatitis? a case-control study.

Market trends in baby skin care products and implications for clinical practice.

Topical emollient application in term healthy newborns: a systematic review.

J Glob Health

Emollients in infancy to prevent atopic dermatitis: a systematic review and meta-analysis.

Allergy

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Early food intervention and skin emollients to prevent food allergy in young children (PreventADALL): a factorial, multicentre, cluster-randomised trial.

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Skin care and synbiotics for prevention of atopic dermatitis or food allergy in newborn infants: a 2 × 2 factorial, randomized, non-treatment controlled trial.

Int Arch Allergy Immunol

In utero or early-in-life exposure to antibiotics and the risk of childhood atopic dermatitis, a population-based cohort study.

Pet exposure and risk of atopic dermatitis at the pediatric age: a meta-analysis of birth cohort studies.

Influence of household pet ownership and filaggrin loss-of-function mutations on eczema prevalence in children: a birth cohort study.

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Changes in skin barrier function following long-term treatment with moisturizers, a randomized controlled trial.

The effect of aqueous cream BP on the skin barrier in volunteers with a previous history of atopic dermatitis.

Diagnosing atopic dermatitis in infancy using established diagnostic criteria: a cohort study.

Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial.

Disease trajectories in childhood atopic dermatitis: an update and practitioner’s guide.

Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream.

Personal care product use as a predictor of urinary concentrations of certain phthalates, parabens, and phenols in the HERMOSA study.

J Expo Sci Environ Epidemiol

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.
To determine whether emollient intervention in infants not selected for risk reduces AD incidence by age 24 months.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03409367.

Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial.

Emollients to Prevent Pediatric Eczema

Papers