NCT07184645

A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 3 Months – 14 Years
• Healthy volunteers: Not accepted

Summary

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	OPA-15406	0.3% foam or 1% foam, topical, twice daily, for 8 weeks
DRUG	Vehicle	vehicle, topical, twice daily, for 8 weeks

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Japan