LISBON, Portugal — The regular application of an emollient on the skin of babies in their first year of life does not prevent eczema, according to results from two large clinical trials.
“One hundred thousand oil baths performed for nothing,” said Håvard Skjerven, MD, PhD, from Oslo University Hospital in Norway.
He reported results from this “very large project” here at the European Academy of Allergy and Clinical Immunology 2019 Congress. “There were 20 PhD students involved, all taking part in clinical examinations.”
In the Preventing Atopic Dermatitis and Allergies in Children, or PreventADALL (NCT02449850), study, Skjerven and his colleagues recruited expectant mothers during a routine ultrasound appointment. Participants were excluded if there were more than two fetuses, if infants were born before 35 weeks of gestation, or if infants were born with severe disease.
The day after delivery, 2397 infants were randomized to one of four groups: 575 to a skin intervention, 642 to a food intervention, 583 to both the skin and food interventions, and 597 to no intervention.
For the skin intervention, babies were bathed in water with liquid paraffin and trilaureth-4-phosphate oil and their faces were covered with Ceridal cream. Compliance was defined as an oil bath and cream application at least 3.5 days a week for 16 of 25 weeks.
All babies were breast-fed, but those in the food-intervention groups were introduced to peanut, milk, wheat, and egg between 3 and 6 months.
Cases of Atopic Dermatitis
At 12 months, 2172 infants were assessed for atopic dermatitis, the primary outcome of the study; 224 participants were lost to follow-up and one withdrew consent.
The results were not as expected. At 12 months, atopic dermatitis was more common in infants who received either the skin or food intervention than in infants who received both or neither intervention (11.1% vs 9.0% vs 5.3% vs 8.1%; P = .003).
Numbers were similar in the four groups for the secondary outcome of possible atopic dermatitis (16.5% vs 16.0% vs 10.8% vs 15.9%).
The development of atopic dermatitis was not delayed or prevented with early skin-barrier enhancement or with complementary food introduction, said Skjerven. In fact, the interventions “possibly enhanced” the onset of atopic dermatitis, he reported.
The Barrier Enhancement for Eczema Prevention (BEEP) trial (ISRCTN21528841) produced similarly disappointing results, reported by Robert Boyle, MB ChB, PhD, from the University of Nottingham in the United Kingdom.
Another Study, Same Negative Result
Boyle and his colleagues looked at rates of eczema in a cohort of 2-year-old children who had been randomized to an intervention or control group shortly after birth. All had a direct relative diagnosed with eczema, allergic rhinitis, or asthma.
Parents of the 693 babies in the intervention group were provided with and told to apply a double-based gel or cream emollient for 12 months. Parents of the 701 babies in the control group were asked not to apply any creams or gels.
Compliance in the intervention group — application of the emollient at least 3 days a week — was 74%, and in the control group — no emollient — was 85%.
We felt pretty depressed about these results.
At 2-year follow-up, data were available on 598 children in the intervention group and 612 in the control group. Rates of eczema were similar in the intervention and control groups (23% vs 25%; adjusted relative risk, 0.95; P = .61).
The first onset of eczema, reported by parents, was similar in the intervention and control groups at the end of the first year (20% vs 20%) and at the end of the second year (31% vs 32%).
Not only did the emollient not reduce eczema, it actually appeared to lead to more skin infection and a possible increase in immunoglobulin E food allergy. However, he explained, the BEEP study was underpowered to determine that.
If the increase in food allergy “pans out in other studies,” then it supports the hypothesis that food allergies come in through the skin, he added. Were lipids rubbed into the skin of these infants through the moisturizers? “We don’t know.”
Small Studies Showed Efficacy of Emollient
“Emollients are the mainstay of treatment for those with already established eczema,” said Maeve Kelleher, MD, from Imperial College of London.
“There were a lot of positive results, and yes, this is where intervention was going to go for eczema and potentially other atopic diseases,” she said. “But both the Norwegian trial and the BEEP trial didn’t show an effect with the intervention.”
Clinicians are currently recommending emollients, “so where does that leave us?” she asked. “Are all emollients created equal?”
Most creams are regulated by the cosmetics industry. Maybe they need more medicinal properties, “but then they would be more expensive,” she added.
At this point, “the benefit of emollient therapy is not clear,” Kelleher explained.
This “does not mean we should not put cream on our children,” said Claudia Hülpüsch, PhD, from the University of Munich.
“There is still a lot of evidence that emollients make a change,” she told Medscape Medical News. Although these two studies show the contrary, “there are European and Asian studies that show putting emollient on kids’ skin helps.”
For other researchers, these results present a real setback.
“This was a huge disappointment,” said Christina West, MD, PhD, from Umeå University in Sweden. “We thought that emollients would be the key.”
Skjerven, Boyle, Kelleher, Hülpüsch, and West have disclosed no relevant financial relationships.
European Academy of Allergy and Clinical Immunology (EAACI) 2019 Congress: Session HT 2 (Boyle) and abstract TP0986 (Skjerven). Presented June 2 and 3, 2019.