U.S., Nov. 5 -- ClinicalTrials.gov registry received information related to the study (NCT07916480) titled 'Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis' on Oct. 30.
Brief Summary: This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.
Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will ass...