Topical Roflumilast Effective in 4 Weeks for Atopic Dermatitis in Young Children.

A phase 3 study presented at the American Academy of Dermatology's annual meeting found that treatment with topical roflumilast, 0.05%, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD). The study included 652 patients, with 437 assigned to roflumilast cream and 215 assigned to a vehicle cream. The results showed that 25.4% of patients treated with roflumilast reached the primary endpoint of "clear" or "almost clear" plus a two-grade improvement from baseline at week 4, compared to 10.7% in the vehicle group. The study also found that itch improved within 24 hours of starting treatment. Safety data showed that 29.7% of patients taking roflumilast had treatment-emergent adverse effects, compared to 21.9% in the vehicle arm. Dermatologists believe that topical roflumilast could be an important new treatment option for children with AD, as there are currently few nonsteroidal options available. [Extracted from the article]