Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology

• ZORYVE® (roflumilast) cream 0.05% improved atopic dermatitis (AD) across all primary and secondary efficacy endpoints, with significant improvement as early as Week 1 on multiple efficacy endpoints.  
• 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint.
• Children treated with ZORYVE cream experienced improvement in itch as early as 24 hours. 
• Efficacy and safety results were consistent with previous trials of ZORYVE cream 0.15% in adults and children with AD down to age 6.  
• Approximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States. 
• Supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% submitted to the U.S. Food and Drug Administration (FDA).  

WESTLAKE VILLAGE, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Pediatric Dermatology published online positive results from INTEGUMENT-PED, the pivotal phase 3 randomized vehicle-controlled trial evaluating the efficacy and safety of ZORYVE (roflumilast) cream 0.05% as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in children 2 to 5 years old.  

The study found that treatment with investigational once-daily ZORYVE cream 0.05% resulted in significant improvements across multiple efficacy endpoints, including achieving a statistically significant improvement in the primary efficacy endpoint of IGA Success, as well as statistically significant improvements in additional endpoints, including 75% improvement in the Eczema Area and Severity Index (EASI-75) and Worst Itch Numeric Scale (WI-NRS) at Week 4. The data also show improvement in itch (pruritus) was observed as early as 24 hours after first application. 

“AD is a chronic, inflammatory skin disease affecting 1.8 million children ages 2 to 5 in the United States with burdensome symptoms that often result in impaired quality of life for both patients and their caregivers,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and lead author on the publication. “Results from the INTEGUMENT-PED trial demonstrate that ZORYVE cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch. The publication of these results and the entire clinical development program highlight that ZORYVE cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers.” 

INTEGUMENT-PED is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 children were enrolled in the study, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%.  

As previously reported, at Week 4, 25.4% of children treated with ZORYVE cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P