A Multinational, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis
This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.
• Hospitalization status: Outpatient.
• Age: 15 to 70 years old, inclusive (at time of obtaining informed consent), either male or female (only for 4 weeks double blind treatment).
• Able to provide written informed consent. For subjects under 18 years old (Korea: 19 years old), written informed consent must be obtained from both the subject and the subject's legal guardian.
• Diagnosis of AD based on the criteria of Hanifin and Rajka. (See Appendix 1).
• History of AD for at least 3 years.
• Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit (only for 4 weeks double blind treatment).
• IGA score of 2 or 3 at the screening and baseline visit (only for 4 weeks double blind treatment).