Significance of Roflumilast Approval for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

Roflumilast cream 0.05% (Zoryve), a non-steroidal topical designed for the treatment of mild to moderate atopic dermatitis in children ages 2 - 5 years, was approved by the US Food and Drug Administration (FDA) on October 6, 2025.1,2

The approval of roflumilast cream 0.05 % followed recent trial data confirming the drug’s safety and efficacy as a long-term alternative to topical corticosteroids for children. To discuss these data and the approval’s significance in atopic dermatitis, HCPLive spoke with Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at UC San Diego’s School of Medicine.

“I think that basically…in this age group, it's the families that come in with incredible concerns about topical corticosteroids, probably overblown concerns about them,” Eichenfield explained. “Then [they’re] coming up with regimens of care that they're comfortable with, when they're uncertain about the safety of some topical products. This can very much limit the ability for us to control the rationale of eczema. In this younger age group, there's a lot of dry skin barrier dysfunction, often pretty significant body surface area, even in many mild patients.”

This approval of roflumilast was based on results from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study.1

Eichenfield highlighted that, following roflumilast cream’s approval, having a specific product developed for this age group that is an effective non-steroidal with strong tolerance is notable. He also highlighted the low levels of stinging and burning and the strong efficacy and safety record of roflumilast.

“The part of the gap that we face is what we can do to have patients and families use a medicine as liberally as needed for effective clearance,” Eichenfield said. “I mean, I really push for minimal rash, minimal itch, and minimal sleep disturbance, and especially in this 2 - 5 year old age group, there's a ton of sleep disturbance which impacts the whole family. So if I have a highly effective agent, it can be used in different parts of the body. You don't need multiple prescriptions for different areas.”

Eichenfield has previously reported grants and personal fees from Arcutis, as well as from Amgen, AbbVie, Dermavant, Galderma, Incyte, Eli Lilly, Pfizer, Regeneron, and Sanofi.

References

1. Brooks A. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed October 8, 2025. https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years.

2. Arcutis Biotherapeutics. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5. October 6, 2025. Accessed October 8, 2025. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-005-treatment.