The last subject has been enrolled in the INTEGUMENT-INFANT Phase 2 study of investigational once-daily roflumilast cream, 0.05% (Zoryve, Arcutis) in infants with mild-to-moderate atopic dermatitis (AD).
The INTEGUMENT-INFANT Phase 2 study is evaluating the safety and tolerability of roflumilast cream, 0.05% applied once daily over a four-week period in 101 infants aged three months to less than 24 months with mild-to-moderate AD. The study builds upon the earlier Maximal Usage (MUSE) pharmacokinetics trial ARQ-151-105, which also evaluated roflumilast cream, 0.05% in this age group.
Top-line results from the study are expected to be reported in Q1 2026.
“Enrollment in the INTEGUMENT-INFANT study has been brisk, reflecting strong interest from parents seeking an alternative to topical corticosteroids. This clinical milestone represents a significant step in advancing a well-tolerated topical treatment for this vulnerable population, for whom FDA-approved options remain limited,” says Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, in a news release.
“We eagerly anticipate the study results as we continue to develop ZORYVE cream 0.05% as a potential new treatment for pediatric atopic dermatitis in infants as young as three months.”
