RALEIGH, N.C. – Once-daily application of an emollient from birth through age 6 months has shown considerable promise as a means of preventing atopic dermatitis, according to the Barrier Enhancement for Eczema Prevention study.
BEEP was a multicenter, international, randomized controlled pilot study assessing the feasibility, safety, and effectiveness of a novel approach to the prevention of atopic dermatitis. The study hypothesis was that protecting the skin barrier early in life can prevent this common skin disease, explained Dr. Eric L. Simpson of Oregon Health and Science University, Portland.
Dr. Eric L. Simpson
The rationale for this approach lies in previous work demonstrating that skin barrier dysfunction precedes eczema development. And emollients can be effective in treating mild disease and preventing flares, he said at the annual meeting of the Society for Investigative Dermatology.
BEEP involved 124 infants in Portland and at four medical centers in the United Kingdom. All were deemed high risk for atopic dermatitis because they had one or more first-degree relatives with a history of asthma, hay fever, or atopic dermatitis. Participating families were randomized to either once-daily application of an emollient to the baby’s entire body except the scalp and diaper area starting before age 3 weeks and continuing for 6 months, or to a control group that agreed to refrain from regular use of emollients. All families received advice on best-practice skin care, namely to minimize the use of harsh cleansers and hot water bathing.
The 6-month cumulative incidence of investigator-diagnosed eczema was 21.8% in the daily emollient group, compared with 43.3% in controls, for a 67% reduction in risk. It was a considerably more dramatic effect than what the investigators had anticipated.
"This was kind of a surprising finding to us," Dr. Simpson admitted. Patients will be followed up at 1 and 2 years to learn whether the early-life treatment actually prevented or simply delayed onset of atopic dermatitis.
In a subanalysis, skin barrier function studies were carried out in 15 patients divided between a control and intervention arm. Children in the control arm showed favorable albeit nonsignificant trends for less transepidermal water loss and a lower skin pH.
Parents in the intervention arm were given a choice of three emollients of various viscosities: sunflower seed oil; Cetaphil cream in the United States or Doublebase gel in the United Kingdom; or Aquaphor in the United States or 50-50 ointment, a white soft paraffin/liquid paraffin product marketed in the United Kingdom. More than two-thirds of families opted for Cetaphil cream or Doublebase gel.
Ninety-six percent of families in the intervention arm found their emollient acceptable, and 80% indicated they used it at least 5 days per week.
No cases of irritant or contact dermatitis occurred in the emollient group. Three mild skin infections occurred in each study arm.
Dr. Simpson’s BEEP coinvestigators included atopic dermatitis experts such as Dr. Hywel C. Williams, professor of dermatology at the University of Nottingham (England) and Dr. Jon M. Hanifin, professor emeritus of dermatology at Oregon Health and Science University.
The researchers are now planning a larger, definitive, randomized controlled trial of emollient therapy early in life as a means of preventing the development of atopic dermatitis. This study will be powered to look at the relative efficacy of different emollients. Also, it will include objective measures of adherence, such as volume of emollient used, rather than simply relying upon parental report.
Audience members expressed enthusiasm over the BEEP findings. The prevalence of atopic dermatitis has been rising for decades; the disease exacts a steep toll in terms of quality of life; and to date, there has been no established eczema prevention strategy. Moreover, there is the prospect that by preventing eczema via a simple topical therapy it will be possible to halt the "atopic march" to asthma and other comorbidities.
Dr. Simpson noted that BEEP was a small-scale feasibility study carried out because investigators were initially unsure if families would be willing to participate in a clinical trial where they could be randomized to avoiding emollients. But 28%-59% of the families approached at the participating centers agreed to enroll.
BEEP was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Oregon Clinical and Translational Research Institute, and the U.K. National Institute for Health Research.
Dr. Simpson reported having no financial conflicts of interest.