Significant improvement in pruritus seen within 24\u2009hours of first application<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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\u2009years, according to a study published online Feb. 20 in Pediatric Dermatology<\/em>.<\/p>\n 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\u2009years with AD. The analysis included 437 patients randomly assigned to receive roflumilast and 215 patients randomly assigned to vehicle cream.<\/p>\n 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\u2009hours 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 (\u22640.7 percent) at all time points.<\/p>\n “These results suggest roflumilast cream 0.05 percent may provide a novel topical treatment option for patients aged 2 to 5\u2009years with mild-to-moderate AD,” the authors write.<\/p>\n Several authors disclosed financial ties to pharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.<\/p>\n