Clinical Data
Results from the Phase 2 Proof-of-Concept Study in Atopic DermatitisIn the Phase 2 proof-of-concept study in atopic dermatitis (AD), 136 patients were randomized to roflumilast 0.15%, roflumilast 0.05% or vehicle once-daily for 4 weeks. Patients had 1.5–35% body surface area (BSA) affected by AD, with a validated investigator global assessment AD (vIGA-AD) score of 2 (mild) or 3 (moderate), and eczema area and severity index (EASI) score of ≥5. The primary efficacy endpoint was absolute change from baseline in EASI score at Week 4.Study results showed that once-daily roflumilast cream demonstrated efficacy when compared to vehicle in AD. Although the primary endpoint in this proof of concept study showed a trend towards, but did not reach statistical significance, statistical significance for other efficacy endpoints was reached. Statistically significant improvements compared with vehicle were observed at Week 4, including 72.3% EASI improvement and >50% of patients achieving clear or almost clear skin on vIGA-AD for roflumilast cream 0.15%. Roflumilast cream was well tolerated, with a low rate of application site reactions, and no local irritation.