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A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Summary
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)
Key Details
Gender
All
Age Range
3 Months - 14 Years
Study Type
INTERVENTIONAL
Enrollment
198
Start Date
2025-09
Completion Date
2027-02
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
OPA-15406
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
Vehicle
vehicle, topical, twice daily, for 8 weeks
Locations (1)
Sumire Dermatology Clinic
Tokyo, Japan