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In a randomized trial involving 1247 infants, daily full-body application of bland emollients reduced overall atopic dermatitis (AD) incidence at age 2 by 16%. The strongest preventive effects occurred in children at low AD risk and those with household dogs. Given the trial’s pragmatic design and the popularity of moisturizers, investigators said, their approach may provide a safe, practical route for reducing AD burden — and perhaps a blueprint for future dermatologic trials.

For the Community-based Assessment of Skin Care, Eczema, and Allergies (CASCADE) trial, researchers led by senior investigator Eric L. Simpson, MD, MCR, randomized healthy infants up to 8 weeks old recruited from 25 primary care practices in four US states. Parents of treated infants chose one of five over-the-counter moisturizers, which were selected by dermatologists and pediatric eczema experts, for mail delivery every 6 months. Simpson is the Frances J. Storrs Medical Dermatology Professor at Oregon Health and Sciences University in Portland, Oregon. The study was recently published online in JAMA Dermatology.

Treatment instructions included applying the emollient to the entire body (except the scalp and diaper area, if desired) once daily and bathing children twice weekly with a gentle cleanser for 24 weeks. Most control-group parents applied the emollient one or fewer times weekly, only when the skin appeared dry.

Based on primary care clinician-reported health records, cumulative incidence rates of AD at 2 years in the treatment and control groups were 36.1% and 43.0%, respectively, with a relative risk (RR) of 0.84 (95% CI, 0.73-0.97; P = .02) for treated patients. Somewhat surprisingly, low-risk infants — such as those with no family history of atopy — experienced heightened effects, with treated patients achieving an AD incidence reduction of 10.1 percentage points, or a 24% reduction, vs untreated low-risk infants.

Additionally, children in the study with pet dogs experienced a relative risk reduction of about 32% vs those without dogs. Although studies have shown that the presence of dogs generally protects children against eczema development, the mechanism remains unclear. In the CASCADE study, Simpson told Medscape Dermatology, having a dog did not just help prevent eczema but also it enhanced the intervention effects. Perhaps both the emollient and the dog support a microbial environment that calms the immune system, he speculated. Alternatively, low-risk families might be more open to having a dog than high-risk families, although the study did not examine such issues.

Straightforward Solution

When parents or expectant parents ask if there’s anything they can do to reduce their baby’s risk of developing eczema, Simpson said, the study showed that daily application of a bland moisturizer is a safe, straightforward approach, and that the emollients studied can deliver potential health benefits whether children are at risk for AD or not. In a prior study he coauthored, up to 70% of families used moisturizer on their babies. So did 64% of CASCADE families at baseline. “It’s a relatively common practice in the United States,” Simpson said.

The challenge going forward, said Simpson, is that daily moisturization worked better for children without a first-degree relative with asthma, allergic rhinitis, or eczema. Low-risk families may not think to ask about eczema prevention, he said, because they are less worried about it than high-risk families. Getting the word out will require more research, he said, ideally starting with a cost-benefit analysis that might convince insurers to cover the intervention for all families.

Simpson and colleagues’ study contradicts prior studies that found no impact of various emollient regimens in infants without eczema, noted authors led by Cathryn Sibbald, BScPhm, MD, MSc, assistant professor of dermatology at the University of Toronto, Toronto, Ontario, Canada, in an accompanying editorial. Additionally, the mean enrollment age of 24 days in the CASCADE study was older than in most other studies, with randomization occurring at birth or shortly after.

“There is evidence to support that neonatal skin has increased permeability and an underdeveloped stratum corneum,” she and her editorial coauthors wrote, “and that this changes substantially during the first few weeks of life.” The preenrollment use of moisturizers by many participants may have conferred baseline protection (or harm) that requires further study, they added.

Family-Friendly Design

Simpson said that the most exciting element of the study was the collaboration with family medicine and pediatricians’ offices that are part of practice-based research networks. No dermatology offices were involved. Consent, randomization, and data collection were handled electronically from a central hub.

Moreover, the pragmatic study design included no requirements for study visits. This element helped investigators retain around 85% of participants for 2 years, which Simpson said is a very high rate, especially for a pediatric study. Although the study design made strict monitoring impossible, he added, eschewing in-person visits helped investigators enroll a large, representative US sample, pandemic notwithstanding.

In an interview, Joseph M. Lam, MD, who was not involved with the study, added that infants in primary care were the perfect population to examine because this is the patient group where eczema initially presents and where the interventions of the study can be first implemented. He is a clinical professor of pediatrics at the British Columbia Children’s Hospital and an associate member in the Department of Dermatology and Skin Sciences at The University of British Columbia, both in Vancouver, British Columbia, Canada.

As significant as the study’s results, Simpson added, is the fact that its design mimicked real-world conditions as much as possible — a rarity in dermatologic studies. “I’m looking forward to using that as a standard for studying new questions in the field,” he said.

At press time, Simpson and his team were preparing for a community-based study of how new-onset eczema treatments affect disease course and comorbidity development. Emerging data from Japan have suggested that how one treats early eczema can affect food-allergy risk over time. Although overuse of topical steroids by these researchers proved problematic, Simpson said, the study demonstrates conceptually that initial eczema treatment can impact long-term health.

Cost Concerns

Regarding study limitations, CASCADE investigators acknowledged that full-body moisturization might prove too costly, difficult, or time-consuming for some families.

“These days,” said Lam, “it is fairly easy to find moisturizers, depending on where you live. The fact that researchers allowed a choice between five different moisturizers means that hopefully, families can find one that is cost-effective and available.” Study emollients, which patients could switch mid-study if desired, included CeraVe Healing Ointment, CeraVe Moisturizing Cream (L’Oreal products), Cetaphil (Galderma), Vanicream (Pharmaceutical Specialties), and petrolatum. Based on a quick ChatGPT (OpenAI) query, he said, their costs average around $1 per ounce.

Among the many items that new parents might spend money on, Lam said, daily moisturizing provides excellent value, especially if it can prevent the wide-ranging impacts of eczema, including patient discomfort, additional treatment costs, sleep disturbances, and family disruption. If parents weigh the tedium of daily full body moisturization against the value of reducing eczema incidence by up to 24%, he added, “that might be worthwhile.” Additional positive spillover effects could include deeper bonding with their infant and developmental improvement through physical touch, he noted.

“Parents do many things that are not easy, but they’re done because of positive benefits, value, and love,” he said. “And this can definitely be one of them.”

This study was funded by the National Institutes of Health. Emollient manufacturers provided free study products, but these companies had no impact on the study or publication. Simpson reported receiving personal fees and grants and/or serving as an investigator for companies including AbbVie, Amgen, Arcutis, Eli Lilly, and others outside of the emollient study. Lam has been an investigator, advisory board member, and speaker and received honoraria from Sanofi Genzyme. He also has been an advisor and/or received honoraria from Johnson & Johnson, Pierre Fabre, Pfizer, and Valeant. Additionally, Lam has been an advisor/speaker for Celltrion and has received honoraria from AbbVie, Incyte, La Roche-Posay Canada, and Beiersdorf Canada.

John Jesitus is a Denver-based freelance medical writer and editor.