A 4-week phase 3 trial, INTEGUMENT-PED, demonstrated the safety and efficacy of roflumilast cream 0.05% in children aged 2–5 years with mild-to-moderate atopic dermatitis (AD). An open-label extension trial subsequently evaluated outcomes over 56 weeks of continued treatment in 562 patients. At week 56, roflumilast maintained improvements in AD signs and symptoms, with 63.1% of patients achieving a Validated Investigator Global Assessment for AD (vIGA-AD) score of 0/1 (clear/almost clear).
Among patients who switched to twice-weekly application, 30.2% achieved a median duration of 238 days of “disease control.” The treatment was well tolerated, with application-site pain reported in four patients. These findings support the long-term safety and sustained efficacy of roflumilast cream in young children with atopic dermatitis. ##Reference## Eichenfield LF, Gonzalez ME, Boguniewicz M, et…
