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Roflumilast Cream Meets Primary Endpoint for Treatment of Atopic Dermatitis


Roflumilast cream .05% for mild to moderate atopic dermatitis in children also met secondary endpoints.

Arcutis Biotherapeutics, Inc announced that the INTEGUMENT-PED phase 3 trial of roflumilast cream .05% met primary and secondary endpoints for treatment of mild to moderate atopic dermatitis (AD) in children ages 2 to 5 years.1 In the parallel group, double-blind, vehicle-controlled trial, 25.4% of children treated with roflumilast cream .05% achieved Investigator Global Assessment (IGA) Success compared with 10.7% of children treated with vehicle (P < .0001) at week 4.

Марина Терехова/AdobeStock

Марина Терехова/AdobeStock

The steroid-free topical cream is used once daily and formulated to deliver the drug without disrupting the skin barrier. INTEGUMENT-PED evaluated roflumilast cream in 652 children with a mean Body Surface Area (BSA) of 22% overall.

Roflumilast cream also met all secondary endpoints, including 39.4% of children achieving 75% improvement in Eczema Area and Severity Index (EASI-75), and 35.3% of children treated with roflumilast cream reaching a 4-point reduction in Worst Itch Numeric Scale (WI-NRS) compared to 18% of children treated with vehicle at week 4.

“Atopic dermatitis is a chronic disease that is unstable in its course. EASI-75 has emerged as an important endpoint in clinical trials and reflects clinically meaningful responses in the real world. EASI incorporates body surface area, and higher body surface area involvement is an important consideration for the severity and impact of the disease for patients suffering from pediatric atopic dermatitis,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, professor, Director of Clinical Research, and Director of Patch Testing at George Washington University School of Medicine and Health Sciences in Washington, DC, in a press release.

Incidence of adverse events (AEs) during the trial was low, with the most common AEs in the roflumilast cream treated arm (≥ 2%) being upper respiratory tract infection, pyrexia, diarrhea, and vomiting. Of the children randomized to receive roflumilast cream, 93.8% completed the 4 weeks of the study, with few discontinuing due to AEs (1.1% in the roflumilast group vs 1.9% in the vehicle group).

Arcutis Biotherapeutics recently announced submission of a supplemental New Drug Application to the US Food and Drug Administration for roflumilast cream .15% for treating mild to moderate AD in adults and children aged 6 years and older.


  1. Arcutis announces positive results from INTEGUMENT-PED pivotal phase 3 trial of roflumilast cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. September 19, 2023. Accessed September 19, 2023. https://www.globenewswire.com/news-release/2023/09/19/2745482/0/en/Arcutis-Announces-Positive-Results-from-INTEGUMENT-PED-Pivotal-Phase-3-Trial-of-Roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html
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