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Arcutis' ZORYVE cream gets strong AAD recommendation for pediatric atopic dermatitis

April 22, 2026 8:04 AM

Arcutis Biotherapeutics Inc. (NASDAQ: ARQT) announced that its ZORYVE cream received a strong recommendation in the American Academy of Dermatology's clinical practice guidelines for managing pediatric atopic dermatitis.

The AAD guidelines recommend ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis. The recommendation was supported by high certainty of clinical evidence, according to the press release.

ZORYVE is a topical phosphodiesterase type 4 inhibitor containing roflumilast. The AAD guidelines recognized the treatment's efficacy, safety, and tolerability based on multiple randomized controlled trials showing improvements in clinical signs, itch, and patient-reported outcomes.

The most common adverse reactions for ZORYVE cream 0.05% in pediatric patients aged 2-5 years were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache. For ZORYVE cream 0.15% in patients 6 years and older, the most common adverse reactions were headache, nausea, application site pain, diarrhea, and vomiting.

Atopic dermatitis affects approximately 9.6 million children in the United States. The condition is a chronic, inflammatory skin disease that can impact quality of life for patients and caregivers.

The pediatric guidelines were developed using systematic evidence review and included 27 evidence-based recommendations covering topical therapies, phototherapy, and systemic treatments for children and adolescents under 18 years of age.

"Since atopic dermatitis is a lifelong condition that often begins in childhood, when the immune system and skin barrier are still developing, it is critical to have therapies that balance efficacy with long-term safety and tolerability," said Patrick Burnett, chief medical officer at Arcutis.

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