Subgroup Analysis Demonstrates Efficacy of Roflumilast Cream for AD in Pediatric Patients With Diverse Skin Types

A recent poster presented at the 2026 Winter Clinical Hawaii Dermatology Conference in Maui detailed the results of a subgroup analysis of INTEGUMENT-PED (NCT04845620) for roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics), which evaluated treatment response among pediatric patients with atopic dermatitis (AD) across a diverse range of skin types. Overall, results from INTEGUMENT-PED demonstrated that roflumilast cream is well tolerated and effective for diverse patient populations with AD.¹

The rationale behind the study acknowledges that the epidemiology and clinical presentation of AD often differ based on a patient’s race, ethnicity, and Fitzpatrick skin type. Roflumilast cream 0.05% was approved for mild to moderate AD in pediatric patients aged 2 to 5 years in October 2025. The approval was based on data from the INTEGUMENT-PED and INTEGUMENT-OLE (NCT04804605) trials, which demonstrated that roflumilast cream 0.05% produced rapid improvement in disease severity and clinically meaningful improvement in itch.^1,2

"Roflumilast 0.05% cream for young pediatric AD patients fills an unmet need for effective and safe non-steroidal topicals in young children who do not require systemic therapy or as adjunctive therapy for those on systemic therapy who require additional topical care," said Christoper Bunick, MD, PhD, associate professor of dermatology at the Yale School of Medicine and editor in chief of Dermatology Times, in an exclusive statement regarding roflumilast’s approval.

Background

INTEGUMENT-PED was a phase 3, parallel-group, double-blind, vehicle-controlled study in patients aged 2 to 5 years with AD for 6 weeks or more that was stable for 4 weeks or longer. Roflumilast cream 0.05% or vehicle cream was applied once daily by a parent and/or caregiver for 4 weeks.

Key end points of INTEGUMENT-PED included:

• vIGA-AD success, defined as clear (0) or almost clear (1) plus ≥2-grade improvement
• vIGA-AD 0/1
• EASI 75, defined as ≥75% improvement in EASI
• WI-NRS success, defined as ≥4-point improvement in patients with baseline score ≥4
• Safety and application-site tolerability

Results

Among the 651 enrolled patients, 17.4% were Hispanic or Latino, 15.4% were Black/African American, and 8.3% were Asian. Roflumilast cream 0.05% improved signs and symptoms of AD compared with vehicle cream overall and across race, ethnicity, and Fitzpatrick skin type subgroups at 4 weeks of treatment

Roflumilast was well tolerated, with treatment-related adverse events reported for 15 (3.4%) patients. Across time points, investigators reported no evidence of irritation at the application site in approximately 93% of patients treated with roflumilast. Caregivers of 2 patients (0.5%) reported a hot, tingling, or stinging sensation with definite discomfort following the first application of roflumilast, with similar sensations reported in fewer than 1% of patients at later assessments. Application-site pain was reported as an adverse event in 7 patients (1.6%) in the roflumilast group and 4 patients (1.9%) in the vehicle group.

At week 4:

• 33.8% of Hispanic/Latino patients achieved vIGA-AD success compared with 23.6% of non-Hispanic/Latino patients
• 41.8% of Hispanic/Latino patients achieved EASI 75 compared with 39.2% of non-Hispanic/Latino patients
• 34.5% of patients with Fitzpatrick skin type I-III and 36.8% of patients with Fitzpatrick skin type IV-VI achieved WI-NRS success

Overall, 4 weeks of treatment with roflumilast cream 0.05% led to improvements in signs of AD in children aged 2 to 5 years across a broad range of diverse skin types. Efficacy and safety outcomes were generally consistent with those observed in patients aged 6 years and older with AD enrolled in the 4-week INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600) trials. Roflumilast cream 0.05% was well tolerated, with no or minimal evidence of application-site irritation, including after the first application. Collectively, findings from the INTEGUMENT-PED trial support roflumilast cream 0.05% as a well-tolerated and effective treatment option for diverse pediatric patient populations with AD.

References

1. Prajapati VH, Eichenfield LF, Browning JC, et al. Once-daily roflumilast cream 0.05% for the treatment of atopic dermatitis in patients aged 2–5 years with diverse skin types: subgroup analysis from the phase 3 INTEGUMENT-PED trial. Poster presented at: 2026 Winter Clinical Hawaii Dermatology Conference; January 16-21, 2026; Maui, HI
2. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis Biotherapeutics. October 6, 2025. Accessed January 16, 2026. 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