FDA Expands Indication for Roflumilast to Treat Atopic Dermatitis in Children Ages 2 to 5

The FDA has approved roflumilast (Zoryve; Arcutis) cream 0.05% for once-daily treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, providing clinicians with a steroid-free alternative for long-term management of pediatric eczema.

The approval, announced October 6, 2025, marks the sixth FDA authorization for roflumilast in just move than 3 years and provides an essential option for the estimated 1.8 million children in this age group in the US who receive topical treatment for atopic dermatitis.

INTEGUMENT Phase 3 Outcomes

The FDA decision was based on clinical trial data from the INTEGUMENT-PED and INTEGUMENT-OLE phase 3 trials. The pediatric-specific trial demonstrated that 25.4% of children treated with roflumilast cream 0.05% achieved Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) success at Week 4, defined as a vIGA-AD score of clear or almost clear plus a 2-grade improvement from baseline, compared with 10.7% of children treated with vehicle (P <.001). Additionally, more than one-third (39.4%) of children using roflumilast cream achieved EASI-75 (75% reduction in Eczema Area and Severity Index) at treatment week 4 compared with 20% using vehicle, with differences observed as early as week 1.

"It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis 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 and INTEGUMENT study investigator, said in a statement. "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," Eichenfield stressed.

The INTEGUMENT-PED trial enrolled 652 children ages 2 to 5 years (n=437 treated with roflumilast cream, n=215 vehicle) in a randomized, double-blind, vehicle-controlled, parallel-group study that evaluated once-daily application for 4 weeks. In an exploratory analysis, more than one-third of children who had a baseline Worst Itch Numeric Scale (WI-NRS) score of 4 or greater reach a 4-point reduction in WI-NRS at at week 4 compared with 18% for vehicle-treated children (nominal P =.002), with some caregivers reporting reduced itching within 24 hours after first application.

Roflumilast cream 0.05% was well tolerated in the pivotal studies with low levels of local irritation reported and adverse events similar to those observed with vehicle treatment. The cream is formulated without common sensitizing agents, such as propylene glycol, polyethylene glycol, ethanol, and fragrances, making it suitable for use on sensitive skin areas, including the face, neck, and intertriginous regions.

Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, reduces inflammation by inhibiting the release of pro-inflammatory cytokines and increasing production of anti-inflammatory mediators. The 0.05% concentration was formulated specifically for pediatric patients to achieve optimal efficacy with a favorable safety margin. Clinicians can use the cream on any affected skin area and may apply it continuously or intermittently as part of long-term disease management.

"[Roflumilast] cream was intentionally formulated to address the critical unmet need in atopic dermatitis care, and it provides a safe, effective alternative to steroid treatments, targeting the underlying inflammation that drives disease activity," Frank Watanabe, president and chief executive officer of Arcutis, said in a statement. He reiterated that the cream uses no ingredients known to compromise the skin barrier, "which is especially important for young children with atopic dermatitis. [Roflumilast] provides patients and their families with a treatment option for long-term, continuous use, helping maintain clear skin and limiting cumulative topical steroid exposure."

Arcutis plans to make roflumilast cream 0.05% widely available through wholesalers and pharmacies by the end of October 2025, according to the statement. Importantly, the Zoryve Direct Program is available to help caregivers and patients navigate the payer process. In addition, the Arcutis Cares patient assistance program provides medication at no cost for financially eligible uninsured or underinsured individuals.

1. FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis. October 6, 2025. Accessed October 6, 2025. https://www.globenewswire.com/news-release/2025/10/06/3161656/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html
2. Halsey G. Long-term roflumilast data show durable efficacy in young children and adults with atopic dermatitis. Patient Care. June 6, 2025. Accessed October 6, 2025. https://www.patientcareonline.com/view/long-term-roflumilast-data-show-durable-efficacy-in-young-children-and-adults-with-atopic-dermatitis