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Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE® (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis
58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4Investigational ZORYVE cream 0.05%
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4Investigational ZORYVE cream 0.05% was well tolerated and demonstrated a safety profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatmentAtopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first yearThe Company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for this age group in Q2 2026 WESTLAKE VILLAGE, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the INTEGUMENT-INFANT Phase 2 study evaluating the safety, tolerability, and efficacy of ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis. ZORYVE cream, a highly selective and potent topical phosphodiesterase 4 (PDE4) inhibitor, was well tolerated with a safety profile consistent with previous ZORYVE clinical trials. Overall, the incidence of adverse events was low, with all being mild to moderate in severity. ZORYVE cream improved the severity of disease and reduced the area of skin affected by atopic dermatitis, with 58% of participants achieving EASI-75 at Week 4. “Atopic dermatitis is the most common type of eczema and often starts in infancy. 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,” said Mercedes E Gonzalez, MD, pediatric dermatologist and co-founder of Dermatology360 and INTEGUMENT-INFANT investigator. “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.” The Phase 2 study results reinforce the consistency of the safety and tolerability profile of ZORYVE cream 0.05% already seen in the four-week pivotal INTEGUMENT-PED clinical trial in children ages 2 to 5 years. The most frequently reported adverse events (≥3%; n=101) included: d...