Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials
For the primary endpoint, 25.4% of children treated once daily with roflumilast cream 0.05% achieved Investigator Global Assessment (IGA) Success compared to 10.7% of children treated with vehicle (P