Mercedes Gonzalez, MD, discusses phase 2 trial of roflumilast cream 0.05% for infant atopic dermatitis

On June 10, 2025, Arcutis Biotherapeutics announced that the first infant was enrolled in the INTEGUMENT-INFANT study, a phase 2 clinical trial evaluating investigational roflumilast cream 0.05% for atopic dermatitis (AD) in children aged 3 months to under 2 years. The open-label study will assess the safety and tolerability of once-daily treatment in approximately 35 infants with mild to moderate AD over a 4-week period.

Roflumilast, a topical phosphodiesterase-4 inhibitor, is already approved in various formulations and concentrations for several dermatologic indications across older pediatric and adult populations. The cream formulation has been approved in concentrations of 0.3% and 0.15% and is currently under FDA review for the 0.05% concentration in children aged 2 to 5 years.

Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, emphasized the burden of AD in infants and the lack of approved treatment options. “Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in pediatric dermatology,” Burnett stated at the time of enrollment.

Mercedes E. Gonzalez, MD, board-certified pediatric dermatologist; clinical assistant professor at Florida International University Herbert Wertheim School of Medicine and the Phillip Frost Department of Dermatology at Miller School of Medicine; medical director at Pediatric Skin Research in Miami, Florida; and an investigator in the INTEGUMENT-INFANT trial, expands on the significance of the study in the Q&A below.

Q&A with Mercedes Gonzalez, MD

Contemporary Pediatrics: What do treatment options currently look like for populations younger than 2 years who have AD?

Mercedes Gonzalez, MD: Today, infants under 2 years with AD face a significant gap in FDA-approved treatment options. While topical corticosteroids are often prescribed as first-line treatment, there are limited FDA-approved treatment options.

Contemporary Pediatrics: Generally speaking, how much of an impact does AD have on this younger age group, and is it more or less frequent in this group compared with other pediatric age groups?

Gonzalez: AD impacts 9.6 million children in the United States,² and up to 60% of children with AD develop symptoms within their first year.³ The disease in this age group often presents as red, scaly patches on the cheeks, chin, and scalp, which can severely disrupt sleep and increase the risk of skin infections.

Contemporary Pediatrics: How encouraging is it that there is a treatment study being conducted in this age group, and do providers feel this is a group that needs a treatment indication?

Gonzalez: Enrolling the first infant in this study represents an important milestone in our efforts to better understand potential treatment options for this underserved population. Given the chronic nature of AD and the lack of existing approved therapies for infants, we are encouraged by the opportunity.

Contemporary Pediatrics: Is there anything else you would like to include related to this study, roflumilast, or AD in the younger populations?

Gonzalez: AD in infants is more than just a skin condition; it can disrupt development, sleep, and quality of life for the entire family. Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants. This means new clinical research is critically important for this age group.

Topical roflumilast approved indications

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

Currently, roflumilast is approved for the following indications, according to Arcutis¹:

• Roflumilast foam 0.3% is approved to treat plaque psoriasis of the scalp and body in adults and pediatric patients 12 years or 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 9 years or 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 or 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 6 years or 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 (sNDA) 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 of October 13, 2025.

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%.

Editor's note: Mercedes Gonzalez, MD, reported the following disclosures:

Speaker, investigator, consultant and/or advisory board member for AbbVie, Abeona, Alphyn, Amgen, Amryt, Anterogen, Arcutis, CeraVe, Dermavant, Eli Lilly, Galderma, Incyte, Kenvue, Krystal Biotech, Leo, Nielsen Biosciences, Noblepharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Unilever, and Verrica Pharmaceuticals.

References

1. Fitch J. First infant enrolled in trial of roflumilast cream, 0.05% for atopic dermatitis in infants. Contemporary Pediatrics. June 10, 2025. Accessed June 27, 2025. https://www.contemporarypediatrics.com/view/first-infant-enrolled-trial-roflumilast-cream-0-05-atopic-dermatitis-infants
2. Atopic dermatitis. National Eczema Association. Accessed June 27, 2025. https://nationaleczema.org/types-of-eczema/atopic-dermatitis/
3. Frazier W, Bhardwaj N. Atopic dermatitis: diagnosis and treatment. Am Fam Physician. 2020;101(10):590-598.