Arcutis Biotherapeutics eczema treatment cream Roflumilast met primary endpoints
Arcutis Biotherapeutics announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children using roflumilast cream 0.05% achieved skin improvement by Week 4, compared to 10.7% in the control group. Improvement was noticeable as early as Week 1.
Roflumilast cream 0.05% is a once-daily steroid-free topical cream in development, that is formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%. The data reinforce the well-established efficacy, safety and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.
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