Arcutis Completes Enrollment in Phase 2 Study of Roflumilast Cream for Infant AD

Today, Arcutis Biotherapeutics, Inc. announced completion of enrollment in its INTEGUMENT-INFANT phase 2 clinical study, evaluating the safety and tolerability of roflumilast cream 0.05% (ZORYVE) in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD).¹

The trial builds upon findings from the earlier ARQ-151-105 Maximal Usage trial, which examined the pharmacokinetics of roflumilast cream in this same age group. Topline results are anticipated in early 2026.

“Atopic dermatitis often presents in infancy and can cause significant discomfort from the itch and rash, and even disruption to sleep and social activities, which can negatively impact the affected child and the entire family,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Enrollment in the INTEGUMENT-INFANT study has been brisk, reflecting strong interest from parents seeking an alternative to topical corticosteroids. This clinical milestone represents a significant step in advancing a well-tolerated topical treatment for this vulnerable population, for whom FDA-approved options remain limited. We eagerly anticipate the study results as we continue to develop ZORYVE cream 0.05% as a potential new treatment for pediatric atopic dermatitis in infants as young as three months.”¹

Study Design and Methodology

A poster presented at the 2025 Society of Pediatric Dermatology meeting first outlined the design of the 4-week, open-label, single-arm trial.² The primary objective of INTEGUMENT-INFANT is to evaluate the safety and tolerability profile of roflumilast cream 0.05% when administered once daily (QD) for 4 weeks. Secondary objectives include the assessment of various exploratory efficacy outcomes.

Participants will be infants aged 3 to 24 months with a clinical diagnosis of AD for at least 6 months prior to screening. Crucially, eligible infants must present with an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at baseline, indicating their disease severity. Furthermore, the body surface area (BSA) affected by AD must be between 5% and 20% at baseline.

Endpoints and Assessments

The primary endpoint of the INTEGUMENT-INFANT study focuses on safety and tolerability. This will be comprehensively assessed through the monitoring of adverse events (AEs), changes in vital signs, and laboratory abnormalities throughout the 4-week treatment period. Physical examinations will also be conducted at each visit to further evaluate the safety profile.

In addition to safety, several exploratory efficacy endpoints will be evaluated at week 4 to gain preliminary insights into the potential therapeutic benefits of roflumilast cream in this population. These include:

• IGA Success: Defined as an IGA score of 0 (clear) or 1 (almost clear), reflecting a significant improvement in overall disease severity.
• Percent Change from Baseline in Eczema Area and Severity Index (EASI): The EASI score is a widely used objective measure of AD severity, assessing the extent and intensity of erythema, induration/papulation, excoriation, and lichenification.
• Percent Change from Baseline in Worst Itch-Numeric Rating Scale (WI-NRS): For subjects aged 6 months and older, the WI-NRS will quantify the reduction in the most bothersome symptom of AD.
• Percent Change from Baseline in Patient-Oriented Eczema Measure (POEM): This patient-reported outcome measure assesses the impact of AD on daily life.
• Percent Change from Baseline in Dermatology Life Quality Index (DLQI): For subjects aged 6 months and older, the DLQI evaluates the impact of skin disease on a patient's quality of life.
• Sleep Disturbance: Assessment of improvements in sleep patterns, a common issue for infants with AD.
• Caregiver Global Assessment (CGA): A caregiver-reported measure of the infant’s overall AD severity.

Expert Perspective

In an interview with Dermatology Times, Mercedes E. Gonzalez, MD, pediatric dermatologist based in Miami, Florida, medical director of Pediatric Skin Research, and study investigator, shared her anticipation for this research.

“There's a large unmet need for non-steroid topical treatments in this population. So that's where roflumilast 0.05% cream would fit in very nicely as something that can not only treat the signs and symptoms of eczema in young infants, but also perhaps induce barrier repair, prolonged remissions, and adequate disease control. We're very much looking forward to it,” she said.

References

1. Arcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis. News release. Globe Newswire. Published November 13, 2025. Accessed November 13, 2025. https://www.globenewswire.com/news-release/2025/11/13/3187274/0/en/Arcutis-Completes-Enrollment-in-INTEGUMENT-INFANT-Phase-2-Study-Evaluating-ZORYVE-roflumilast-Cream-0-05-in-Infants-with-Atopic-Dermatitis.html

2. 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.