Addressing Unmet Needs in Infant Atopic Dermatitis With Roflumilast Cream 0.05%

Patrick Burnett, MD, PhD, chief medical officer at Arcutis Biotherapeutics, outlined key data supporting last week’s supplemental new drug application (sNDA) for roflumilast cream 0.05% for infants with atopic dermatitis (AD). The submission is based on findings from the INTEGUMENT-INFANT trial, an open-label study evaluating safety and efficacy in 101 infants aged 3 to 24 months with mild to moderate disease over a 4-week period.

Safety outcomes were consistent with prior studies in older pediatric populations. The most commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and infrequent vomiting—findings considered expected in this age group. Importantly, no new safety signals emerged, supporting the tolerability of the formulation in very young patients.

Efficacy results were notable across multiple clinically relevant endpoints. Approximately one-third of patients achieved Investigator’s Global Assessment (IGA) success, defined as clear or almost clear skin with at least a two-grade improvement. Additionally, 58% reached EASI-75 by week 4.

The study also highlighted improvements in scalp involvement, an often underrecognized manifestation in infants, with 67.5% of affected patients achieving scalp-specific success. Rapid itch relief was another key finding; nearly half of patients experienced at least a 25% reduction in pruritus within 10 minutes of the first application, based on caregiver-reported outcomes.

Burnett emphasized the importance of formulation in this age group, noting that the unique once-daily 0.05% cream is free of common sensitizing excipients such as fragrances, propylene glycol, and ethanol. This aligns with standard counseling for infant AD and supports its use in sensitive, developing skin. The therapy may also help address “steroid phobia” and safety concerns among caregivers by offering a nonsteroidal option suitable for long-term disease management. Once-daily application further enhances its practicality for families managing chronic AD.

“As we move into these earlier ages, all the way down to 3 months, this is a time period where not only is the immune system evolving and maturing through that time period, but also the skin itself is undergoing changes in maturation during this time. So these patients tend to be very, very sensitive,” Burnett reminded.

Looking ahead, he noted a broader trend toward increased pediatric drug development in dermatology, particularly for inflammatory diseases. Despite this progress, unmet needs remain, especially in common conditions such as acne, underscoring the need for continued innovation across the pediatric dermatology landscape.

“It is fantastic to now see them starting to move earlier into treatment, where oftentimes we've had really limited access for patients to innovative treatments,” Burnett concluded. “[But] where I'd like to challenge everyone is to see if we can find something to help out all of our patients with acne, which we see a lot in the pediatric population.”

For more atopic dermatitis news and research, register to attend the 2026 Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, held June 17-19. Use code DT40 for 40% off registration.