Topline Phase 2 Data Show Roflumilast Cream Improves Atopic Dermatitis in Infants as Young as 3 Months

Topline results from a phase 2 clinical trial suggest that roflumilast cream 0.05%, a topical phosphodiesterase 4 inhibitor, was well tolerated and improved disease severity in infants with mild to moderate atopic dermatitis, according to a press release from Arcutis Biotherapeutics.

The INTEGUMENT-INFANT phase 2, open-label, multicenter study evaluated once-daily roflumilast cream 0.05% applied for four weeks in 101 infants aged 3 months to less than 24 months. Investigators reported that 58% of participants achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 4.

Overall, roflumilast cream was well tolerated, with a safety profile consistent with previous clinical trials of the drug. The incidence of adverse events was low, and all reported events were mild to moderate in severity. No serious adverse events were reported, and only one participant discontinued the study because of an adverse event.

“Atopic dermatitis is the most common type of eczema and often starts in infancy. For our youngest patients, it’s critical to have therapies that are both safe and effective and that can be used on all body areas, including the face and diaper region,” said Mercedes E Gonzalez, MD, a pediatric dermatologist and INTEGUMENT-INFANT investigator. “These data underscore the potential of investigational ZORYVE cream 0.05% to provide meaningful improvements in the signs and symptoms of atopic dermatitis, while reinforcing its well-established and consistent safety profile.”

The findings build on prior pediatric data from the four-week pivotal INTEGUMENT-PED trial in children aged 2 to 5 years. In the infant study, the most frequently reported adverse events (≥3%) included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.

INTEGUMENT-INFANT also builds on results from the earlier Maximal Usage (MUSE) pharmacokinetics trial (ARQ-151-105), which evaluated roflumilast cream 0.05% in the same age group.

“Reaching this clinical development milestone for ZORYVE through the INTEGUMENT-INFANT study underscores our commitment toward providing safe, effective non-steroidal treatment options for even the youngest patients with atopic dermatitis who have substantial disease burden and very limited treatment options today,” said David Berk, MD, FAAD, vice president of research and development strategy and clinical development at Arcutis. “Based on my experience as a pediatric dermatologist, demonstrating efficacy and tolerability in infants — using a formulation specifically developed with young children suffering from atopic dermatitis in mind—not only advances our development program but gives hope to our patients and their families who are suffering with the burdensome symptoms of atopic dermatitis.”

Atopic dermatitis affects an estimated 9.6 million children and 16.5 million adults in the US and often presents within the first year of life, with approximately 60% of children developing symptoms during infancy. In infants and young children, disease involvement is often widespread and commonly affects the face, neck, and extensor surfaces.

Roflumilast cream is already approved for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years (0.05% formulation) and in pediatric and adult patients aged 6 years and older (0.15% formulation). The drug is contraindicated in patients with moderate to severe hepatic impairment.

According to the press release, results from the INTEGUMENT-INFANT study support continued development of roflumilast cream 0.05% for infants, a population with limited nonsteroidal topical treatment options.

Reference: Arcutis announces positive topline results for INTEGUMENT-INFANT phase 2 trial of Zoryve (roflumilast) cream 0.05% in infants with mild to moderate atopic dermatitis. News release. Arcutis Biotherapeutics. February 2, 2026. Accessed February 2, 2026. https://www.globenewswire.com/news-release/2026/02/02/3230196/0/en/Arcutis-Announces-Positive-Topline-Results-for-INTEGUMENT-INFANT-Phase-2-Trial-of-ZORYVE-roflumilast-Cream-0-05-in-Infants-with-Mild-to-Moderate-Atopic-Dermatitis.html