Overview
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-02-28
2024-02-28
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Otsuka Beijing Research Institute
Criteria
Inclusion Criteria:1. Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining
informed consent).
2. Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
3. 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.