AAD Pediatric Guidelines Give Strong Backing to Roflumilast Cream

Key Takeaways

• ZORYVE (roflumilast) cream received a strong recommendation with high-certainty evidence in the AAD’s first pediatric atopic dermatitis (AD) guidelines.
• The topical PDE4 inhibitor is recommended for children aged ≥2 years with mild to moderate disease, with favorable efficacy and tolerability.
• The guideline underscores topical therapies as the cornerstone of pediatric AD management.

Arcutis Biotherapeutics announced that ZORYVE (roflumilast) cream has received a strong recommendation in the American Academy of Dermatology (AAD) clinical practice guidelines for pediatric atopic dermatitis (AD), marking inclusion in the organization’s first guideline focused on patients younger than 18 years.

The guidelines recommend roflumilast cream 0.05% for children aged 2 to 5 years and 0.15% for those aged 6 years and older with mild to moderate AD. Treatment across studies has shown improvements in disease severity and pruritus, as well as low discontinuation rates. The multidisciplinary guideline panel used a systematic review and GRADE framework to evaluate 27 recommendations spanning topical, phototherapy, and systemic interventions. Within the topical phosphodiesterase-4 inhibitor class, roflumilast cream received a strong recommendation based on consistent improvements in clinical and patient-reported outcomes and a favorable tolerability profile.

“The AAD’s strong recommendation for ZORYVE cream, building on its previous strong recommendation in adults, reflects the high certainty of evidence supporting its efficacy, low rates of treatment discontinuation, and favorable tolerability in pediatric patients," said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a press release. "These evidence-based recommendations help clinicians make informed treatment decisions for children, adolescents, and their caregivers managing this chronic condition and reinforce the value of ZORYVE as a topical PDE4 inhibitor. Since AD 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. ZORYVE does not include ingredients or irritants known to compromise the skin barrier, which is especially important in these age groups.”

Source: Arcutis press release. April 22, 2026.