Roflumilast Cream 0.05 Percent Safe, Effective in Young Children With Eczema

FRIDAY, March 14, 2025 (HealthDay News) — Once-daily roflumilast cream 0.05 percent is safe and effective for atopic dermatitis (AD) in patients ages 2 to 5 years, according to a study published online Feb. 20 in Pediatric Dermatology.

Lawrence F. Eichenfield, M.D., from the University of California San Diego in La Jolla, and colleagues conducted a phase 3 trial evaluating the efficacy and safety of roflumilast cream 0.05 percent among patients ages 2 to 5 years with AD. The analysis included 437 patients randomly assigned to receive roflumilast and 215 patients randomly assigned to vehicle cream.

The researchers found that significantly greater proportions of participants in the roflumilast group achieved Validated Investigator Global Assessment for AD Success at week 4 (25.4 versus 10.7 percent), 75 percent improvement in the Eczema Area and Severity Index (39.4 versus 20.6 percent), and Worst Itch-Numeric Rating Score Success (35.3 versus 18.0 percent). Within 24 hours after the first application, improvement in pruritus was seen. Both groups had low rates of treatment-emergent adverse events, of which 98.9 percent were mild or moderate. Caregivers of patients in the roflumilast group reported stinging/burning that caused definite discomfort (≤0.7 percent) at all time points.

“These results suggest roflumilast cream 0.05 percent may provide a novel topical treatment option for patients aged 2 to 5 years with mild-to-moderate AD,” the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.

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