Roflumilast Cream Shows Long-Term Promise for Young Children with Atopic Dermatitis

For children aged 2 to 5 years with atopic dermatitis (AD), roflumilast cream 0.05% demonstrates a favorable long-term safety profile and sustained effectiveness for up to 56 weeks, according to recent research published in Pediatric Dermatology.

Study Details and Findings

The study, led by Dr. Lawrence F. Eichenfield from the University of California-San Diego School of Medicine, was a phase 3 open-label extension of the INTEGUMENT-PED trial (INTEGUMENT-OLE). Researchers investigated the long-term outcomes of continuing roflumilast cream treatment in children with mild-to-moderate AD.

In the INTEGUMENT-OLE trial, caregivers applied roflumilast cream 0.05% once daily. Patients who achieved clear or almost clear skin (vIGA-AD 0/1) after four weeks switched to a twice-weekly application schedule.

The results indicated that roflumilast was well-tolerated. Among 562 patients, only 14 (2.5%) experienced treatment-related adverse events (AEs). Application-site pain was reported in four patients (0.7%).

At week 56, a significant 63.1% of patients showed continued improvement, achieving a vIGA-AD score of 0/1. For the 170 patients (30.2%) who transitioned to twice-weekly application, the median duration of sustained “disease control” was 238 days.

Expert Commentary

“Providing safe, effective nonsteroidal treatment options for young patients—who can have substantial disease burden but have limited available therapies—remains an important goal in pediatric dermatology,” said Dr. Eichenfield. “The publication of these data reinforces Zoryve cream 0.05% as a meaningful, long-term treatment option for children living with atopic dermatitis and their families.”

Study Details and Funding

The study, titled “Long‐Term Safety and Efficacy of Once‐Daily and Proactive Twice‐Weekly Roflumilast Cream 0.05% for Mild‐to‐Moderate Atopic Dermatitis in Children Aged 2–5 Years From a 52‐Week, Phase 3 Trial (INTEGUMENT‐OLE),” was published in Pediatric Dermatology on March 8, 2026.

several authors disclosed financial ties to Arcutis Biotherapeutics, the manufacturer of roflumilast, as the study was funded by the company.