Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis

Favorable topline findings from the phase 2 INTEGUMENT-INFANT study have been announced regarding the efficacy and safety of roflumilast cream 0.05% (Zoryve) in infants between 3 months and under 24 months of age with atopic dermatitis.1

This February 2 announcement by Arcutis Biotherapeutics, Inc. highlighted the safety, tolerability, and clinical activity of roflumilast cream in this particular age range. Atopic dermatitis, impacting an estimated 9.6 million children and 16.5 million adults in the US, maintains a varied clinical presentation across age cohorts.

“Atopic dermatitis is the most common type of eczema and often starts in infancy,” Mercedes E. Gonzalez, MD, pediatric dermatologist and co-founder of Dermatology360 and INTEGUMENT-INFANT investigator, said in a statement.1 “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.”

Roflumilast cream is a topical formulation of a highly potent and selective phosphodiesterase 4 (PDE4) inhibitor. PDE4 is an intracellular enzyme known to play a significant role in inflammatory signaling pathways, and it is a well-established therapeutic target in dermatology. Through the inhibition of PDE4, roflumilast can diminish the production of pro-inflammatory mediators, leading to decreased cutaneous inflammation and improved immune regulation.

During the open-label, multicenter INTEGUMENT-INFANT phase 2 analysis, Gonzalez and colleagues looked at 101 infants with mild to moderate atopic dermatitis. Those enrolled as participants would receive roflumilast cream 0.05% once-per-day for 4 weeks, with the primary aim being assessing safety and tolerability. This trial followed earlier work from the ARQ-151-105 Maximal Usage (MUSE) pharmacokinetic study, an analysis also evaluating roflumilast cream 0.05% in infants of this same age cohort.2

Roflumilast cream therapy was generally shown to be well tolerated, with its safety profile aligning with prior roflumilast clinical study results. Adverse event (AE) occurrences were shown to be infrequent overall and limited to mild or moderate severity.

Additionally, Gonzalez et al observed clinically meaningful improvements in disease severity and extent, as more than half of treated infants demonstrating substantial improvement. Specifically, the investigative team observed attainment by 58% of participants of a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) scores by the 4-week mark.

“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,” Gonzalez said in her statement.1

These findings further support the consistency of the safety and tolerability profile of roflumilast cream 0.05% observed in earlier pediatric studies, including the four-week pivotal INTEGUMENT-PED trial conducted in children aged 2 to 5 years.

In the infant study, the most commonly reported adverse events, each occurring in at least 3% of participants, included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one participant discontinued treatment because of an adverse event, and no serious adverse events were reported during the study period.

“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,” David Berk, MD, Arcutis vice president of R&D strategy and clinical development, said in a statement.1

References

1. 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. Arcutis Biotherapeutics. 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.

2. Carmona-Rocha E, Rusiñol L, Puig L. Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology. Pharmaceutics. 2025 Jan 12;17(1):91. doi: 10.3390/pharmaceutics17010091. PMID: 39861739; PMCID: PMC11769339.