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Clinical trial

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects With Atopic Dermatitis

ID
Name
271-403-00013
Description
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.
Trial arms
Trial start
2023-02-17
Estimated PCD
2024-11-30
Trial end
2025-05-31
Status
Recruiting
Phase
Early phase I
Treatment
0.3% OPA-15406 Ointment
Twice-daily administration for 4 weeks.
Arms:
0.3% OPA-15406 Ointment
1% OPA-15406 Ointment
Twice-daily administration for 4 weeks.
Arms:
1% OPA-15406 Ointment
0% OPA-15406 vehicle
Twice-daily administration for 4 weeks.
Arms:
0% OPA-15406 Vehicle
Size
240
Primary endpoint
Success rate in Investigator's Global Assessment at Week 4
4 weeks
Eligibility criteria
Inclusion Criteria: 1. Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment). 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(only for 4 weeks double blind treatment). Exclusion Criteria: 1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

2 products

1 indication

Organization
Otsuka Beijing Research Institute
Product
OPA-15406
Indication
Atopic Dermatitis
Product
OPA-15406 Ointment