Roflumilast cream 0.05% (Zoryve) is safe as a treatment for patients aged 3 months to 2 years with atopic dermatitis, new phase 2 findings from the INTEGUMENT-INFANT trial program suggest.1
These data were presented in a poster during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference. Adelaide Hebert, MD—professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston—spoke with HCPLive about the study and its key takeaways for patients in this age cohort with atopic dermatitis.
“We felt it was critical to include this younger cohort of patients in a special study to better understand their response to roflumilast, and this particular concentration is a bit lower,” Hebert explained. “It’s 0.05% and we know that the skin in an atopic patient is often compromised. The barrier is not as intact as normal skin….It was a four-week study. The patients received the medicine application once daily. There were certain criteria for the patients to be enrolled. They had to have mild to moderate atopic dermatitis, and they were required to have at least 3% body surface area. Patients were not enrolled if they had active infection or if they had another chronic condition, which might have prohibited us from adequately assessing the status of their atopic dermatitis.”
Hebert highlighted that during the course of the study, the patients were enrolled and roflumilast cream 0.05% was provided to the patients aged 3 months to 2 years. Both their progress in terms of atopic dermatitis and any adverse events were recorded by Hebert and coauthors.
Hebert et al’s analysis focused on such endpoints as IGA success as well as percent change from baseline in Eczema Area and Severity Index (EASI), Worst Itch-Numeric Rating Scale (WI-NRS), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).1,2 They also looked at sleep disturbances and Caregiver Global Assessment (CGA) results after using roflumilast cream 0.05%.
“One of the things that was determined in this clinical trial was that the outcome was favorable, and that was, of course, what we anticipated, given that we had such good data on older patients in 4-week studies,” Hebert said. “The delta in terms of placebo versus active drug in our older patients was significant, and it was early in onset. So again, we felt very confident using this lower concentration in our younger cohorts, with the expected outcome that we would see positive results. That is indeed what we were able to achieve during this particular clinical trial.”
To find out any further information about roflumilast cream’s use in this population with atopic dermatitis, view Hebert’s full interview video above. For more from DERM 2025, including research on atopic dermatitis therapies, view the latest conference coverage.
The quotes implemented in this interview summary were edited for clarity.
References
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Hebert A, Eichenfield L, Burnett P, et al. INTEGUMENT-INFANT: A Phase 2, 4-Week Open-Label Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less than 2 Years Old With Mild-to-Moderate Atopic Dermatitis. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 – 26, 2025; Las Vegas, Nevada.
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Hebert A, Eichenfield L, Gonzalez M, et al. INTEGUMENT-INFANT: 4-week open-label safety of roflumilast cream 0.05% in 3-24-month-olds with atopic dermatitis. Poster presented at: The Society for Pediatric Dermatology Meeting 2025. July 23-26, 2025. Seattle, Washington. Accessed August 1, 2025.