Lawrence Eichenfield, MD; and Rocco Serrao, MD, react to roflumilast approval for pediatric atopic dermatitis

A newly approved nonsteroidal topical agent offers pediatricians and caregivers an additional treatment option for young children with atopic dermatitis (AD). Lawrence Eichenfield, MD; and Rocco Serrao, MD, discussed the expanded indication of roflumilast 0.05% cream (Zoryve; Arcutis Biotherapeutics), a phosphodiesterase 4 inhibitor, for children aged 2 to 5 years with mild to moderate AD.

Expanding options for pediatric atopic dermatitis

Eichenfield noted that the approval of roflumilast cream 0.05% cream provides a valuable new tool for clinicians managing AD in very young patients. “I’m excited to have an expanded nonsteroidal agent for very young children with atopic dermatitis,” he said. “It’s a water-based cream that’s approved for topical treatment of mild to moderate atopic dermatitis [for] ages 2 years and older.”

The formulation was specifically designed for this age group, taking into account the larger body surface areas affected by AD in young children.

“Some children intrinsically have barrier dysfunction—skin that’s drier—and when you have inflammation, it makes it even drier,” Eichenfield explained. “This formulation brings moisturizing properties with anti-inflammatory medicine that can be used safely and effectively without limitation of body surface area.”

Addressing caregiver concerns and unmet needs

Both physicians emphasized that nonsteroidal options can help address parental concerns about long-term topical corticosteroid use. “There’s a huge unmet need for patients with AD in that we need nonsteroid options for long-term control,” Eichenfield said. He added that AD can have “a significant impact on the patient and the family,” citing the common issue of sleep disturbance related to itch.

Serrao echoed this sentiment, noting the practical advantages for families. “You can use roflumilast 0.05% cream in these 2- to 5-year-olds once a day, anywhere on the skin where there’s atopic dermatitis,” he said. “It avoids a lot of confusion or potential for misuse because it’s so straightforward in how we can use this drug.”

Clinical trial results show rapid, safe improvement

The approval of roflumilast cream 0.05% was based on results from the phase 3 INTEGUMENT-PED trial, the INTEGUMENT-OLE long-term extension study (NCT04804605), and a phase 1 pharmacokinetic study.

In INTEGUMENT-PED, roflumilast achieved rapid disease clearance, with significant improvement seen as early as week 1. By week 4, 25.4% of children treated with roflumilast reached Validated Investigator Global Assessment for Atopic Dermatitis success—defined as “clear” or “almost clear” skin with at least a 2-grade improvement from baseline—compared with 10.7% using vehicle (P < .0001).

Roflumilast also improved itch and overall disease severity, with 39.4% having achieved Eczema Area and Severity Index of 75% or greater improvement at week 4 compared with 20% with vehicle, with over one-third of caregivers having reported a 4-point or greater reduction in itch scores (vs 18% with vehicle).

The treatment was well tolerated, with low adverse event rates—most commonly upper respiratory infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache. “The data set is very reassuring from a safety standpoint,” said Eichenfield.

Simplifying care for patients and families

Serrao emphasized that incorporating roflumilast into treatment plans can help streamline care for families managing AD.

“Therapy selection is all through a shared decision process,” he said. “If you couple efficacy, safety, and tolerability, hopefully this is the drug that patients are comfortable using and can simplify a routine.”

He added that a once-daily, body-wide application may allow parents and children to focus on life beyond the disease. “They can focus on doing other things besides managing their skin,” Serrao said.

Editor's note: Both Serrao and Eichenfield reported a relevant disclosure to Arcutis.

Reference

Fitch J. FDA approves roflumilast cream 0.05% for atopic dermatitis for children aged 2 to 5 years. Contemporary Pediatrics. October 6, 2025. Accessed October 7, 2025. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-cream-0-05-for-atopic-dermatitis-for-children-2-to-5-years