Arcutis Completes Enrollment for INTEGUMENT-INFANT Study

KEY TAKEAWAYS

• Arcutis has completed enrollment in a Phase 2 study evaluating ZORYVE (roflumilast) cream 0.05% in infants under 2 years with atopic dermatitis (AD).

• The investigational cream is already FDA-approved for use in children ages 2 to 5 as of October 2025.

• Topline results are expected in the first quarter of 2026.

Arcutis Biotherapeutics announced the completion of patient enrollment for the INTEGUMENT-INFANT phase 2 study, according to a press release from the company. 

Researchers for INTEGUMENT-INFANT will be evaluating ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The once-daily topical phosphodiesterase-4 (PDE4) inhibitor received FDA approval in October 2025 for the treatment of mild to moderate AD in children ages 2 to 5 years.

“Atopic dermatitis often presents in infancy and can cause significant discomfort from the itch and rash, and even disruption to sleep and social activities, which can negatively impact the affected child and the entire family,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, in the news release. “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. 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.”

Source: Arcutis Biotherapeutics press release. November 13, 2025.