INTEGUMENT-INFANT: Roflumilast Cream 0.05% Shows Itch and Quality-of-Life Improvements in Infants With AD
Key Takeaways
New INTEGUMENT-INFANT trial data showed caregiver-reported improvements in itch, eczema symptoms, and quality of life among infants aged 3 to younger than 24 months treated with roflumilast cream 0.05%.
At 4 hours after the first application, 66.7% of evaluated infants achieved at least a 25% improvement in itch. Mean POEM scores decreased from 14.5 at baseline to 6.5 at Week 4.
ZORYVE cream 0.05% remains investigational for infants younger than 2 years, with an FDA decision targeted for February 23, 2027.
New data from the INTEGUMENT-INFANT trial showed improvements in caregiver-reported itch, atopic dermatitis symptoms, and quality of life among infants treated with ZORYVE (roflumilast) cream 0.05%, according to findings presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, Arizona.
Arcutis Biotherapeutics reported the findings from 101 infants aged 3 to younger than 24 months with mild to moderate atopic dermatitis.
INTEGUMENT-INFANT Trial Results: Itch, Symptoms, and Quality of Life
Caregivers reported improvements in itch as early as 10 minutes after the first application, with 46.6% of evaluated infants (n = 88) achieving at least a 25% improvement on the Dynamic Pruritus Score. At 4 hours, that proportion increased to 66.7% (n = 87).
Worst Scratch/Itch Numeric Rating Scale success was reported in 10.4% of infants at 24 hours, increasing to 72.7% at the final assessment (n = 77 at both timepoints).
Mean Patient-Oriented Eczema Measure (POEM) scores decreased from 14.5 at baseline to 7.9 at Week 2 (n = 100) and 6.5 at Week 4 (n = 96), reflecting a change from moderate to mild symptom severity.
There were also improvements in aregiver assessments also documented improvements in infant and family quality of life, including sleep, daily activities, emotional well-being, and relationships.
At least 97.9% of infants had no investigator-rated application-site irritation across assessment timepoints, and no serious adverse events were reported. An application to expand its indication to infants aged 3 to younger than 24 months remains under FDA review, with a target action date of February 23, 2027.
Source
Arcutis Biotherapeutics press release. November 13, 2026. ACAAI 2026, ePoster R378.