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Roflumilast Cream Meets Endpoint in Study of Young Children with Atopic Dermatitis


In addition, a supplemental new drug application has been filed for roflumilast cream .15% to treat mild-to-moderate atopic dermatitis in adults and children aged 6 years and older.

Roflumilast cream .05% met the primary and secondary endpoints in a phase 3 trial for the treatment of mild-to-moderate atopic dermatitis (AD) in children ages 2 to 5 years.1 In the INTEGUMENT-PED 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 at week 4, according to a press release from Arcutis Biotherapeutics, the developer of roflumilast.

Roflumilast cream .05% also met all secondary endpoints, including 39.4% of children achieving 75% improvement in Eczema Area and Severity Index, and 35.3% of children treated with roflumilast cream reaching a 4-point reduction in Worst Itch Numeric Scale compared with 18% of children treated with vehicle at week 4.

Adelaide A. Hebert, M.D.

Adelaide A. Hebert, M.D.

“Pediatric atopic dermatitis is a chronic, recurrent inflammatory skin condition that can negatively impact the quality of life of the child and family or caregivers. Children’s skin is uniquely sensitive and finding tolerable therapy is often more challenging. Ideally, sensitive areas such as the face and eyelids need a topical treatment that minimizes stinging and burning and is suitable for long-term use,” Adelaide A. Hebert, M.D., chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston, and INTEGUMENT-PED investigator, said in a press release.

Incidence of adverse events (AE) during the trial was low, with the most common AEs in the roflumilast cream treated arm 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 adverse events

Arcutis recently announced submission of a supplemental new drug application to the FDA for roflumilast cream .15% for treating mild-to-moderate AD in adults and children aged 6 years and older. The submission was based on data from the INTEGUMENT-1 and INTEGUMENT-2 trials. Both studies met the primary endpoint of Investigator Global Assessment – Atopic Dermatitis score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement at week 4. In addition, more than 40% of children and adults treated with roflumilast cream achieved a 75% reduction in Eczema Area and Severity Index at week 4 compared with vehicle. Most treatment emergent adverse events mild to moderate in severity.

Roflumilast cream is a once-daily, steroid-free, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. Roflumilast .3% is marketed as Zoryve for the topical treatment of plaque psoriasis in patients 12 years of age and older.


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

This story originally appeared on Dermatology Times and has been edited.

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