Arcutis Biotherapeutics has enrolled the first patient of a planned phase 2 trial to evaluate investigational roflumilast cream 0.05% to treat atopic dermatitis (AD) among an infant population 3 months to less than 2 years of age, the company announced via a press release on June 10, 2025.¹

Trial details of roflumilast cream 0.05% among infants with AD

The trial will be an open-label study called INTEGUMENT-INFANT, which will evaluate the safety and tolerability of the topical phosphodiesterase-4 (PDE4) inhibitor among approximately 35 infants with mild-to-moderate AD, applied once daily across 4 weeks.

According to Arcutis, the chronic, relapsing, and genetically predisposed skin disease impacts approximately 9.6 million children in the United States, of whom up to an estimated 60% develop symptoms within their first year of life.

"AD is a lifelong chronic condition in children that can impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis, in a statement. "Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants, making new clinical research for tolerable and effective treatments that can be used over a lifetime and can reduce or replace steroids, critically important for this age group. Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in pediatric dermatology.”

Topical roflumilast approved indications

The planned infant trial of roflumilast seeks to build on the multiple already-approved and ongoing trials of the topical AD treatment across varying age groups.

Currently, roflumilast is approved for the following indications, according to Arcutis:

• Roflumilast foam, 0.3% is approved to treat plaque psoriasis of the scalp and body in adults and pediatric patients aged 12 years and older. Click here for more on this indication, which was approved by the FDA on May 22, 2025.
• Roflumilast foam, 0.3% is approved to treat seborrheic dermatitis in adults and pediatric patients aged 9 years and older. Click here for more on this indication, which was approved by the FDA on December 15, 2025.
• Roflumilast cream, 0.3%, is approved for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. Click here for more on this indication, which was approved by the FDA on October 9, 2023.
• Roflumilast cream, 0.15%, is approved to treat mild-to-moderate AD in adult and pediatric patients aged 6 years and older. Click here for more on this indication, which was approved by the FDA on July 9, 2024.

On February 26, 2025, the FDA accepted a supplemental new drug application for roflumilast cream, 0.05%, to treat AD in children aged 2 to 5 years. With the acceptance, the federal agency granted a Prescription Drug User Fee Act date for potential FDA approval set for October 13, 2025.²

Arcutis submitted the sNDA on December 16, 2024, based on data from multiple studies, including the INTEGUMENT-PED (NCT04845620) phase 3 trial involving 652 children with a mean AD Body Surface Area (BSA) of 22%.²

"The data highlight the efficacy of the cream, along with its favorable safety and tolerability profile, which are critical when prescribing a long-term treatment for children with AD,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, and INTEGUMENT-PED clinical trial investigator, said in a statement.

"In children, AD often occurs on sensitive areas like the face and neck. In addition to persistent itching and scratching, AD is associated with a lower quality of life for the affected child and caregiver," said Gonzalez. "If approved, ZORYVE cream 0.05% will provide a new treatment option that offers long-term relief and can help alleviate the disease burden for children and their caregivers.”

Click here for INTEGUMENT-PED data and additional details regarding roflumilast cream, 0.05% for AD in children 2 to 5 years of age.

References:

1. Arcutis enrolls first child in INTEGUMENT-INFANT evaluating Zoryve (roflumilast) cream 0.05% in infants with atopic dermatitis. Arcutis Biotherapeutics. Press release. June 10, 2025. Accessed June 10, 2025. https://www.arcutis.com/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis/

2. Fitch J. FDA accepts roflumilast cream 0.05% sNDA for children with atopic dermatitis. Contemporary Pediatrics. February 26, 2025. Accessed June 10, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-roflumilast-cream-0-05-snda-in-children-with-atopic-dermatitis