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NCT05650320
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD
Conditions: Atopic Dermatitis (AD)
Sex: All
Ages: 2 Years – 14 Years
Phase: PHASE3
Enrollment: 240
Sponsor: Otsuka Beijing Research Institute
Summary
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD.
This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
Eligibility Criteria
Inclusion Criteria:Sex: Either male or female.
Age: 2 to 14 years, inclusive (at time of obtaining informed consent).Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit.Exclusion Criteria:1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
Source: ClinicalTrials.gov (NCT05650320). StuddyBuddy aggregates publicly available trial information.