Arcutis Biotherapeutics presented the results of its Phase 2 INTEGUMENT‑INFANT trial at the 2026 American Academy of Dermatology Annual Meeting in Denver. The study enrolled 101 infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis and evaluated once‑daily 0.05% ZORYVE cream over a four‑week period.
The trial achieved a clear or almost clear skin score (vIGA‑AD 0/1) in 49 % of participants at week 4, up from 24 % at week 2. Ninety‑six infants completed the study, giving the data a robust completion rate of 95 %.
Safety was favorable: no serious adverse events were reported and only one participant discontinued due to an adverse event. Itch relief was rapid, with 72.7 % of infants reporting a ≥4‑point improvement on the Worst Scratch Itch Numeric Rating Scale by week 4. A separate assessment of pruritus using the Dynamic Pruritus Scale showed that 46.6 % of infants experienced at least a 25 % reduction in itch intensity at 10 minutes after application, correcting the earlier misstatement of a four‑hour interval.
These results support Arcutis’s plan to file a supplemental New Drug Application for infants in the second quarter of 2026. The data address a clear unmet need, as current topical options for infants are limited and often involve corticosteroids with long‑term safety concerns. ZORYVE’s non‑steroidal phosphodiesterase‑4 inhibition offers a safer, well‑tolerated alternative that can be applied anywhere on the body.
Dr. Patrick Burnett, Chief Medical Officer, noted that the study “adds important clinical evidence for investigational ZORYVE cream 0.05% in infants 3 to <24 months, demonstrating effectiveness across multiple endpoints and a favorable safety profile.” Dr. Lawrence F. Eichenfield, a presenting investigator, added that the data “provide meaningful improvements in the signs and symptoms of infant atopic dermatitis, offering relief for both patients and families.”
Arcutis has already secured FDA approval for ZORYVE in pediatric patients 2 to 5 years and in adults and older children for atopic dermatitis and psoriasis. The infant data build on this momentum and position the company to broaden its market share in a high‑growth segment, reinforcing the strategic trajectory outlined in its recent guidance and Q4 2025 earnings, which highlighted strong demand and a raised 2026 sales outlook.
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