Implications of Findings on Roflumilast Cream 0.05% for Atopic Dermatitis, with Adelaide Hebert, MD

Adelaide Hebert, MD, a professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston, spoke in a recent interview with HCPLive about her team’s positive findings on the safety of roflumilast cream 0.05% (Zoryve) in patients aged 3 months to 2 years with atopic dermatitis.1,2

This phase 2 trial program, known as INTEGUMENT-INFANT, was highlighted in a poster during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas. After having discussed the main findings, Hebert was asked in this segment of her interview about unmet needs in younger patients with atopic dermatitis.

“What's critically important is we have very few therapeutic options that are available and FDA-approved as young as 3 months of age,” Hebert said. “...We also have some drugs that start at 2 years of age, but knowing that eczema often starts at 3 months of age, we've had an unbelievable gap in therapeutic options. We do have one biologic agent that is FDA-approved down to 6 months of age, and that has helped tremendously. But children are adverse to shots. Some parents don't want their children to undergo a shot, even though it's usually only a once-a-month dosing. So we really are extremely limited with efficacious and safe medicines in the group under 2 years of age. We now hope to bring forward a medication that absolutely will be able to achieve the successful landmarks that the FDA requires.”

Hebert noted that access to a once-daily topical option such as roflumilast cream 0.05% for atopic dermatitis in younger patients who are often averse to injections would be a significant shift in the treatment armamentarium. She was also asked about assessments of symptoms such as itch among patients as young as 3 months of age.

“Certainly, we clearly have to rely on the patients’ parents and guardians to give us the feedback regarding the child's itching,” Hebert said. “We can also look for excoriation, so we can see the telltale signs if the patient is still experiencing itching. Remember that our very, very youngest cohort patient doesn't have the neuromuscular development to do what you and I would do if we had itching…But generally, parents can relay that the total experience is. The sleeping is better, the outlook of the child is better, the total arena for the child is better.”

Hebert later noted that she hopes this data is presented to the US Food and Drug Administration (FDA) and leads to an approval of roflumilast cream 0.05% for atopic dermatitis in young patients.

“But of course, it's up to the FDA, and we respect their input and feedback regarding the clinical trial,” Hebert explained. “Then of course, we are just working on a clinical trial that goes down to 3 months of age. We're very excited to then go forward with data that will enrich the whole profile and capability of Zoryve in the realm of atopic dermatitis, even to the very youngest patients that really warrant and deserve therapy as well. The once-daily therapeutic option with a steroid-free product that has an excellent vehicle, I think, is going to be extremely rewarding for patients, parents, and, of course, the physicians who provide the care.”

For further information on roflumilast cream and its use in this younger patient population, view Hebert’s full interview video above. To find out more from DERM 2025, view our latest conference coverage.

The quotes used in this video summary were edited for clarity.

Hebert has received research grants paid to UTHealth McGovern Medical School-Houston from Arcutis, Brickell Biotech, Dermavant, Galderma, LEO Pharma, Lilly, Mayne Pharma, Ortho Dermatologics, and Pfizer. She has received honoraria from Almirall, Arcutis, Bristol-Myers Squibb, Dermavant, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Mayne Pharma, Ortho Dermatologics, Pfizer, Verrica, and Novan Therapeutics and she serves on data safety monitoring boards for Bausch, GSK, Regeneron, and Sanofi.

References

1. Hebert A. Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD. HCPLive. August 1, 2025. https://www.hcplive.com/view/safety-roflumilast-cream-0-05-infants-toddlers-atopic-dermatitis-adelaide-hebert-md. Accessed August 3, 2025.

2. 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.