FDA Approves Arcutis’ Zoryve (Roflumilast) Cream 0.05% for Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5

On October 3, 2025, the U.S. Food and Drug Administration (FDA) approved Zoryve® (roflumilast) Cream 0.05%, developed by Arcutis Biotherapeutics, Inc., for the treatment of mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years.

This approval expands Zoryve’s indication beyond patients aged six years and older, making it the first topical phosphodiesterase-4 (PDE4) inhibitor approved for this younger age group. The decision provides clinicians and caregivers with a safe, steroid-free topical therapy tailored for early childhood eczema.

About Zoryve (Roflumilast) Cream

Roflumilast is a highly selective phosphodiesterase-4 (PDE4) inhibitor, an enzyme responsible for breaking down cyclic adenosine monophosphate (cAMP). By inhibiting PDE4, roflumilast elevates intracellular cAMP levels, which leads to the suppression of pro-inflammatory cytokines, thereby reducing skin inflammation and restore barrier function in AD.

Zoryve Cream 0.05% designed for pediatric-specific formulation with a lower concentration compared to the 0.3% cream approved for psoriasis and older children with AD. It is intended for once-daily application, including sensitive areas such as the face, eyelids, and diaper region, minimizing risks associated with corticosteroids.

About Atopic Dermatitis in Children

Atopic dermatitis is a chronic inflammatory skin disorder marked by intense pruritus (itching), redness, and impairment of the skin barrier function. Globally, up to 20% of children are affected, with many developing symptoms before the age of five. The condition leads to considerable discomfort, risk of secondary infections, and disrupted sleep, significantly lowering quality of life for affected children and their caregivers.

Conventional therapies include topical corticosteroids and calcineurin inhibitors, which, despite their efficacy, pose concerns in young children due to potential side effects like skin thinning, burning sensations, and systemic absorption. This underscores the need for effective non-steroidal treatment alternatives like Zoryve.

Clinical Evidence Supporting FDA Approval

The FDA approval was based on data from the INTEGUMENT-PED Phase 3 clinical trial program, a series of randomized, double-blind, vehicle-controlled studies evaluating the safety, efficacy, and tolerability of once-daily Zoryve Cream 0.05% in children aged 2 to 5 years with mild to moderate AD.

Study Design

The INTEGUMENT-PED Phase 3 trial enrolled pediatric patients aged 2 to 5 years with mild to moderate atopic dermatitis. Participants were randomized to receive either once-daily topical Zoryve Cream 0.05% or a vehicle cream (placebo) for four weeks. The primary endpoint was the proportion of patients achieving Investigator’s Global Assessment (IGA) Success at Week 4, defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Secondary endpoints included changes in the Eczema Area and Severity Index (EASI) and pruritus (itch) severity scores, which provided a broader measure of treatment efficacy and symptom relief.

Results

The trial results showed that Zoryve Cream 0.05% achieved Investigator’s Global Assessment (IGA) Success in over 40% of treated children, compared with approximately 15% in the vehicle group, demonstrating clear superiority over placebo. Improvements in Eczema Area and Severity Index (EASI) and itch severity were evident as early as Week 2, indicating a rapid onset of action. The treatment was also well tolerated, with no serious treatment-related adverse events reported and only mild, infrequent application site reactions observed. Overall, these outcomes support Zoryve Cream 0.05% as an effective, fast-acting, and well-tolerated therapy for young children with mild to moderate atopic dermatitis.

Safety Profile

Zoryve Cream 0.05% demonstrated a favorable safety profile in young children:

• Common adverse events (≤3%): mild application site pain, diarrhea, and headache
• No systemic corticosteroid-like effects or growth suppression
• For topical use only, not to be applied to eyes, mouth, or vaginal areas
• Safety not yet established in children under 2 years of age

Overall, the safety and tolerability results support Zoryve’s use as a long-term, non-steroidal treatment for mild to moderate pediatric AD.

Expert Opinions from Press Release

Commenting on the approval, Dr. Patrick Burnett, Chief Medical Officer at Arcutis Biotherapeutics, said that the milestone reflects the company’s ongoing commitment to delivering safe and effective dermatologic therapies for all age groups. He emphasized that parents and physicians now have a steroid-free option that combines efficacy with convenience. Dr. Lawrence Eichenfield, Professor of Dermatology and Pediatrics at the University of California, San Diego, added that managing eczema in toddlers is often challenging due to concerns about long-term steroid exposure. He noted that roflumilast 0.05% offers a well-tolerated and effective alternative, providing reassurance for both clinicians and families