FDA Approves Roflumilast Cream 0.05% for Atopic Dermatitis in Children 2 to 5

Arcutis Biotherapeutics announced the FDA approval of its supplemental new drug application (sNDA) for roflumilast (Zoryve) cream 0.05% to treat atopic dermatitis (AD) in children aged 2 to 5 years old. According to a Monday news release, the once-daily cream provided rapid and significant clearance of mild-to-moderate AD based on results from the INTEGUMENT studies.¹

“It is essential to have safe and effective treatments for children, who are often diagnosed with AD at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, said in a news release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

Indeed, prior to the roflumilast approval among children aged 2 to 5 years, the standard of care for AD involved an extensive list of treatment approaches and lifestyle interventions. According to the American Academy of Pediatrics’ updated report on managing skin diseases among young patients, topical anti-inflammatories are the recommended therapy for children’s AD. Alongside drugs including corticosteroids and calcineurin inhibitors, children were also instructed to regularly moisturize, bathe frequently, and avoid irritant products.²

READ MORE: FDA Approves Guselkumab for the Treatment of Pediatric Plaque Psoriasis, Psoriatic Arthritis

Now, with the approval of roflumilast among this population, pediatric patients now have a once-daily, steroid-free topical option for treating their AD. With around 1.8 million children in this population having AD, roflumilast could become the standard therapeutic option for children under 5 following the cream’s commercial product release later in the month of October.¹

“In clinical trials, Zoryve cream 0.05% rapidly improved the severity and extent of eczema (AD) signs and symptoms, with approximately 40% of children achieving a 75% improvement from baseline, and more than one-third (35%) achieving a clinically meaningful improvement in itch intensity, both in only 4 weeks,” continued Eichenfield in the news release. “With this approval, health care providers and families have an effective new treatment option for young children with AD.”

The roflumilast cream approval comes from results of the INTEGUMENT-PED (NCT04845620) and INTEGUMENT-OLE (NCT04804605) clinical trials. Throughout these studies, roflumilast cream 0.05% exhibited rapid clearance, a well-tolerated safety profile, and overall positive results across all desired endpoints.¹

INTEGUMENT-PED trial data included both children and adult populations. In this study, 652 children 2 to 5 years old were enrolled, with significant improvements as early as week 1 and further success by week 4 for 25.4% of children treated with roflumilast. Furthermore, with 562 children from INTEGUMENT-PED enrolled in INTEGUMENT-OLE, the follow-up Phase 3 study further demonstrated the safety and efficacy of roflumilast among both children and adults.

“We enrolled Kylie in the Zoryve cream clinical trial when she was 2, which resulted in her skin improving and becoming clear,” Melissa Walters, caregiver of a child who participated in the INTEGUMENT-PED and INTEGUMENT-OLE studies, said in the news release.¹ “I want to share our story to empower other parents to advocate for their children and talk to their health care provider about treatment options that can be used long term.”

While roflumilast cream falls within the category of anti-inflammatories, it has now been expanded as one of the standard steroid-free options for children 2 to 5. With topical corticosteroids and calcineurin inhibitors once being key therapies for treating AD within this population,³ roflumilast now opens the door for parents looking to get their children even faster clearance of the disease, closing an existing and significant gap in pediatric AD.⁴

“Zoryve cream was intentionally formulated to address the critical unmet need in AD care, and it provides a safe, effective alternative to steroid treatments, targeting the underlying inflammation that drives disease activity,” Frank Watanabe, president and CEO of Arcutis, said in the news release.¹ “Zoryve provides patients and their families with a treatment option for long-term, continuous use, helping maintain clear skin and limiting cumulative topical steroid exposure.”

READ MORE: Dermatology Resource Center

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REFERENCES

1. FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News Release. Arcutis Biotherapeutics, Inc. October 6, 2025. Accessed October 6, 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-atopic-dermatitis-in-children-ages-2-to-5/

2. Schoch JJ, Anderson KR, Jones AE, et al. Atopic dermatitis: update on skin-directed management: clinical report. Pediatrics. 2025;155(6):e2025071812. https://doi.org/10.1542/peds.2025-071812

3. Sideris N, Paschou E, Bakirtzi K, et al. New and upcoming topical treatments for atopic dermatitis: a review of the literature. J Clin Med. 2022 Aug 24;11(17):4974. doi: 10.3390/jcm11174974.

4. Karas A. Closing the gap in pediatric atopic dermatitis: experts push for steroid-free advancements. Dermatology Times. May 12, 2025. Accessed October 6, 2025. https://www.dermatologytimes.com/view/closing-the-gap-in-pediatric-atopic-dermatitis-experts-push-for-steroid-free-advancements