Arcutis Reports Positive Phase 2 Data for Infant Atopic Dermatitis Program

Arcutis Biotherapeutics reported positive topline results from the phase 2 INTEGUMENT-INFANT trial evaluating investigational ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to younger than 24 months with mild to moderate atopic dermatitis (AD).

INTEGUMENT-INFANT assessed roflumilast safety, tolerability, and efficacy over four weeks of once-daily treatment. Among treated participants, 58% achieved  at least 75% improvement from baseline in EASI-75 at week 4, which Arcutis noted builds on prior pediatric developments for ZORYVE. The treatment was well tolerated anbd safety was consistent with previous clinical studies. Overall adverse event rates were low and all reported events were mild to moderate in severity. 

“Atopic dermatitis is the most common type of eczema and often starts in infancy," said Mercedes E Gonzalez, MD, pediatric dermatologist and co-founder of Dermatology360 and INTEGUMENT-INFANT investigator, said in the press release. "For our youngest patients, it’s critical to have therapies that are both safe and effective and that can be used on all body areas, including the face and diaper region. These data underscore the potential of investigational ZORYVE cream 0.05% to provide meaningful improvements in the signs and symptoms of atopic dermatitis, while reinforcing its well-established and consistent safety profile.”

Arcutis plans to submit a supplemental New Drug Application for ZORYVE cream 0.05% in this infant population in the second quarter of 2026.

Source: Arcutis press release, February 2, 2026.