Late-Breaking Data: Roflumilast Cream 0.05% Demonstrates Efficacy and Favorable Tolerability in Infantile Atopic Dermatitis

“At 4 weeks, which was the primary end point for the study, from an efficacy standpoint, we had 58% of the patients who met EASI 75,” said Patrick Burnett, MD, PhD, at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado.

Burnett, dermatologist and chief medical officer of Aructis Biotherapeutics, spoke with Dermatology Times’ editor in chief and associate professor of dermatology at Yale School of Medicine, Christopher Bunick, MD, PhD, to discuss late-breaking data on roflumilast cream 0.05% (Zoryve) for infants with atopic dermatitis (AD).^1,2

Data Overview

Findings from the phase 2 INTEGUMENT-INFANT study suggest that once-daily treatment may offer clinically meaningful improvements in both disease severity and pruritus in patients aged 3 months to <24 months, a population with limited nonsteroidal treatment options.

The open-label trial enrolled 101 infants with mild to moderate AD who received once-daily roflumilast cream 0.05% over 4 weeks. Among participants who completed the study (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of clear (0) or almost clear (1) with a ≥2-grade improvement from baseline. Additionally, 49% of infants reached a vIGA-AD score of 0 or 1 at week 4, with early response observed in 24% as early as week 2.

Efficacy outcomes were further supported by Eczema Area and Severity Index (EASI) responses. At week 4, 58.3% of infants achieved EASI 75, compared with 34% at week 2, indicating both rapid onset and continued improvement over time. Notably, among infants with baseline scalp involvement (n=40), 67.5% achieved vIGA-scalp success at week 4, highlighting efficacy in anatomically sensitive areas where topical corticosteroid use may be limited.

“I was very pleased with [the scalp data]. We see a lot of scalp dermatitis that's independent of cradle cap, which is often before 3 months of age, and there's often a lot of scalp disease in infants and younger children with atopic dermatitis,” said Lawrence Eichenfield, MD, during the late-breaking presentation at AAD.

Pruritus reduction, a key driver of disease burden in this population, was also observed. Caregiver-reported outcomes using the Worst Scratch Itch Numeric Rating Scale (WSI-NRS) demonstrated that 72.7% of infants achieved a ≥4-point improvement at week 4, with 60.3% reaching this threshold by week 2. Rapid itch relief was reported, with 46.6% of infants achieving ≥25% improvement on the Dynamic Pruritus Scale (DPS-25) within 10 minutes of application, increasing to 58.6% at 1 hour and 66.7% at 4 hours.

Roflumilast cream 0.05% was generally well tolerated. The most commonly reported adverse events (≥3%) included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one patient discontinued due to an adverse event, and no serious adverse events were reported. Local tolerability was favorable, with ≥97.9% of infants experiencing no application-site irritation throughout the study.

“Here we're thinking about an area where there are very few new approved drugs in these young patients. There are not a lot of choices when you're treating them, and a lot of the patients end up on topical corticosteroids,” Burnett said.

Future Outlook

These findings are consistent with prior pediatric data from the INTEGUMENT-PED trial (NCT04845620) in children aged 2 to 5 years and support the potential role of roflumilast cream as a nonsteroidal, topical phosphodiesterase-4 (PDE4) inhibitor option for infantile AD. Given the chronicity of disease onset in early life and the need for safe, effective, and steroid-sparing therapies, these data may have important implications for clinical practice.

A supplemental New Drug Application for roflumilast cream 0.05% in infants aged 3 months to <24 months is anticipated in 2026.

“This is really exciting with roflumilast being very effective and safe with rapid control of itch in ages 3 months to 24 months. This really opens the door for continuing to advance nonsteroidal topical therapies in pediatric atopic dermatitis,” Bunick said.

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. News release. Arcutis Biotherapeutics. March 28, 2026. Accessed March 28, 2026. https://www.arcutis.com/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/
2. Eichenfield L. INTEGUMENT-INFANT: once-daily roflumilast cream 0.05% in infants aged 3–<24 months with atopic dermatitis. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.