Comparing Roflumilast Cream to Other Topicals for Atopic Dermatitis, With Lawrence Eichenfield, MD

Following the US Food and Drug Administration (FDA) approval of roflumilast (Zoryve) cream 0.05% for atopic dermatitis in patients aged 2 - 5 years, HCPLive interviewed Lawrence Eichenfield, MD, about his team’s data on the new non-steroidal option.1,2

Roflumilast cream’s safety and efficacy as a long-term alternative to topical corticosteroids for children was highlighted in this recent interview by Eichenfield, the 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. In this segment of his interview, he was asked about additional information on the drug.

“This is a classic vehicle control study of children 2 to 5 years of age, mild to moderate atopic dermatitis,” Eichenfield noted. “The application is once-a-day, for a 4-week time course, and with all the [roflumilast] product for atopic dermatitis, similarly in the older age group, they did a 4-week time course…And with the core outcomes, we looked at what percentage of patients get to clear or almost clear, and at least a 2-step improvement. So all the patients who started as mild, to count as [having] treatment success, have to make it totally clear.”

Eichenfield highlighted other elements of these data leading to the FDA approval of roflumilast cream. INTEGUMENT-PED trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study all showed positive results across all efficacy endpoints, with the drug being safe and well-tolerated among study participants.

Eichenfield was asked about the drug’s implementation among children with mild to moderate disease, highlighting its potential for use by caregivers.

“You're not going to, say, use 8 weeks of a steroid and keep using it,” Eichenfield said. “You have a different regimen, because you can't do it that way. I do think that you know they can use it, they can use it as-needed, but it wouldn't be an expectation that they necessarily need to use it every day as they come under control.”

For any additional information on roflumilast cream 0.05% and its use among children with atopic dermatitis, view the interview posted above.

The quotes used in this summary were edited for the purposes of clarity.

Eichenfield 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.