Discussing INTEGUMENT-INFANT and Roflumilast Cream 0.05% in Atopic Dermatitis, With Rocco Serrao, MD

The open-label, phase 2 INTEGUMENT-INFANT clinical study, assessing investigational once-daily roflumilast (Zoryve) cream 0.05%, recently completed enrollment.1

The study is evaluating the safety and tolerability of investigational once-daily roflumilast (Zoryve) cream 0.05% in infants aged 3 months to less than 24 months living with mild to moderate atopic dermatitis. To discuss the significance of this analysis, HCPLive spoke with Rocco Serrao, MD, an associate clinical professor of Dermatology at Wright State University.

“There's such a paucity of these therapies available in the atopic space in general, but then especially in our young ones, especially our infants,” Serrao explained. “Here we're talking a population in this trial, three months of age up to two years. So, [we have] just a real lack of therapies for this population.”

Serrao noted 9.4 million children around the world suffer from the skin disease, with 60% being diagnosed before 1 year of age. Current treatments are limited, Serrao explained, with topical options such as steroids and calcineurin inhibitors often insufficient for long-term management of atopic dermatitis.

The study, as highlighted in a prior interview, is using endpoints such as Investigator's Global Assessment (IGA) success as well as percent change from the point of baseline in Worst Itch-Numeric Rating Scale (WI-NRS), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM).1,2

“Some parents and caregivers are hesitant to put their child on a systemic drug with maybe no end in sight,” Serrao said. “They want to try, hopefully, to avoid putting a systemic treatment in their child's body, no matter how safe it is or how safe it's perceived to be, just because they're concerned as a parent. They may want to try and avoid systemic therapy. There's a huge need for therapies that are topical to manage [atopic dermatitis].”

For additional information, view the full video interview with Serrao posted above.

The quotes contained in this interview were edited for the purposes of clarity.

References

1. 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.

2. Hebert A. Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD. HCPLive. August 1, 2025. Accessed December 11, 2025. https://www.hcplive.com/view/safety-roflumilast-cream-0-05-infants-toddlers-atopic-dermatitis-adelaide-hebert-md.