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Arcutis' ZORYVE® (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis Guidelines

  • Arcutis Biotherapeutics announced ZORYVE (roflumilast) cream received a strong recommendation with high certainty of clinical evidence from the American Academy of Dermatology (AAD) for pediatric atopic dermatitis management.
  • 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.
  • Atopic dermatitis affects approximately 9.6 million children in the United States, often beginning in childhood when the immune system & skin barrier are developing.
  • ZORYVE is a steroid-free topical phosphodiesterase type 4 (PDE4) inhibitor recognized for efficacy, safety, tolerability, & very low treatment discontinuation rates.
  • Common adverse reactions (≥1%) for ZORYVE 0.05% in patients aged 2-5 years include upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, & headache.
  • Common adverse reactions (≥1%) for ZORYVE 0.15% in patients aged 6 years and older include headache, nausea, application site pain, diarrhea, & vomiting.
  • The AAD guidelines emphasize topical therapies as the cornerstone of atopic dermatitis management due to their general effectiveness & lower risk compared to systemic therapies.
  • ZORYVE is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients aged 2-5 years (0.05% cream) & in adult & pediatric patients aged 6 years and older (0.15% cream).
  • ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
  • ZORYVE is the number one prescribed branded topical therapy across atopic dermatitis, seborrheic dermatitis, & plaque psoriasis & has received multiple industry awards including the 2025 Allure Best of Beauty Breakthrough Award.