Safety and Efficacy of Roflumilast Cream for Pediatric Atopic Dermatitis

Experts analyze key clinical trials for roflumilast cream, a PDE4 inhibitor for pediatric atopic dermatitis. The INTEGUMENT-PED trial for children 2 and up featured a robust design: once-daily application, a 4-week primary endpoint with participants averaging 23% BSA involvement. High efficacy and safety were demonstrated, supported by strong patient-reported outcomes. Critical long-term safety data from the open-label extension showed no serious treatment-related adverse events over a year, even with twice-weekly proactive dosing for maintenance. This durability and systemic safety, especially for large surface areas in young children, provide reassurance for steroid stewardship and support a practical long-term management strategy for this chronic inflammatory disease.