INTEGUMENT-INFANT to Test Roflumilast Cream in Children Under Two

Key Takeaways

• Arcutis has initiated a phase 2 open-label study of roflumilast cream 0.05% in infants with mild to moderate atopic dermatitis (AD).

• The trial will evaluate safety and tolerability over a 4-week period in children 3 months to under 2 years.

• This trial expands on data from the ARQ-151-105 (MUSE) study in the same age group.

Arcutis Biotherapeutics has announced the enrollment of the first participants in its new phase 2 INTEGUMENT-INFANT study focusing on the safety and tolerability of ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis (AD).

The trial specifically focused on the once-daily application of roflumilast cream 0.05% over a 4-week treatment period in infants aged 3 months to less than 2 years with AD. The researchers said they will enroll approximately 35 infants with mild to moderate AD affecting at least 3% of body surface area, with an objective of assessing safety and tolerability of the therapy in a very young patient cohort of AD patients.

“AD is a lifelong chronic condition in children that can impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer of Arcutis, in a press release from the company. “Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants, making new clinical research for tolerable and effective treatments that can be used over a lifetime and can reduce or replace steroids, critically important for this age group.”

Source: Arcutis press release. June 10, 2025.