New Data Support Roflumilast Cream in Infants with Eczema Over 4 Weeks, With Lawrence Eichenfield, MD

Roflumilast cream .05% (Zoryve) has demonstrated meaningful efficacy and a favorable safety profile among infants with mild to moderate atopic dermatitis as young as 3 months, according to new data.1

These phase 2 data were presented during a late-breaking podium session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, adding new information to the growing body of evidence behind roflumilast cream for infants aged 3 months to less than 24 months with mild to moderate disease. To discuss these data, HCPLive spoke at AAD with Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at the UC San Diego School of Medicine.

“It had been studied, as you pointed out, in that four week time period, once a day over four weeks,” Eichenfield said. “It was nice that they could do it in a short period of time and show the difference from the vehicle and show efficacy.”

Eichenfield, the presenting author of the INTEGUMENT-INFANT data, opened his discussion by framing the study within the longstanding limitations of topical drugs in this vulnerable patient population. Continuous use of topical corticosteroids is not appropriate for young children, he noted, and even intermittent utilization requires careful management of quantity and frequency.

In this open-label trial, during which 101 infants were evaluated when using roflumilast cream .05% over 4 weeks, there were 96 participants who completed treatment. Eichenfield and colleagues found 34.4% attained validated Investigator Global Assessment (IGA) success and 49% attained a score of clear or almost clear by the fourth week. The team found scalp involvement, present at baseline in 40 of these infants, improved well, with 67.5% showing clearance success at the 4-week mark.

On the Eczema Area and Severity Index (EASI), 58.3% of these participants achieved at least 75% improvement by Week 3, with 34% already attaining this level at Week 2. Eichenfield et al also highlighted the notable caregiver-reported itch outcomes, with more than 72% of infants showing meaningful itch improvement by the 4-week mark, and nearly half showing at least a 25% improvement in their itch level within just 10 minutes of application.

This was a result Eichenfield noted directly in his presentation remarks as evidence of rapid relief for both infants and their families. In terms of safety, roflumilast cream’s profile was described as reassuring and consistent with what was seen in the older INTEGUMENT-PED cohort. There were no serious adverse events observed, as only 1 individual discontinued due to an adverse event. Additionally, at least 97.9% of infants had no application site irritation throughout the analysis.

Arcutis has announced its plans to submit a supplemental New Drug Application (sNDA) for roflumilast cream .05% in infants aged 3 months to less than 24 months in the second quarter of 2026.

Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

References

1. Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting. Arcutis. March 28, 2026. https://www.globenewswire.com/de/news-release/2026/03/28/3264182/0/en/Arcutis-Presents-New-Phase-2-Results-in-Infants-with-Atopic-Dermatitis-in-Late-Breaking-Session-Today-at-the-2026-American-Academy-of-Dermatology-Annual-Meeting.html.

2. Smith T. Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis. HCPLive. February 2, 2026. Accessed March 28, 2026. https://www.hcplive.com/view/positive-topline-data-released-roflumilast-cream-infants-atopic-dermatitis.