GlobeNewswire·Nov 13, 2026, 9:00 AM ET

Arcutis Presents New Caregiver-Reported Outcomes Data Supporting ZORYVE® (roflumilast) Cream 0.05% for Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months at the ACAAI Annual Scientific Meeting

ARQT

Arcutis Biotherapeutics announced new caregiver-reported outcomes from the INTEGUMENT-INFANT trial demonstrating improvements in itch, symptom reduction, and quality of life for infants with atopic dermatitis.
The trial evaluated ZORYVE (roflumilast) cream 0.05% in 101 infants aged 3 to <24 months with mild to moderate atopic dermatitis.
Caregivers reported itch improvements as early as 10 minutes after the first application, with 46.6% of infants achieving ≥25% improvement at that time.
Mean Patient-Oriented Eczema Measure (POEM) scores decreased from 14.5 at baseline to 6.5 at Week 4, indicating a shift from moderate to mild disease severity.
No serious adverse events or severe treatment-emergent adverse events were reported, with 97.9% of infants showing no investigator-rated application-site irritation.
Improvements were observed in infant quality of life (IDQoL) and family quality of life (DFI) regarding sleep, emotional well-being, daily activities, and relationships.
A supplemental New Drug Application (sNDA) to expand ZORYVE approval to infants aged 3-24 months is currently under FDA review with a PDUFA target action date of February 23, 2027.
Current ZORYVE cream 0.05% approval in the US covers children aged 2-5 years, while the investigational data supports potential use in younger infants.
Atopic dermatitis affects approximately 60% of children within their first year of life, creating significant disease burden for families.
The trial findings were presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Phoenix, Arizona.

Company: Arcutis Biotherapeutics, Inc.
Keywords: Nasdaq:ARQT, Arcutis Biotherapeutics, Inc., $ARQT, ZORYVE, ZORYVE Cream, eczema, atopic dermatitis