drugset / Trial / NCT05372653
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
NaSingle-groupOpen-labelTreatment
Summary
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
Timeline
- Start
- 2022-05-23
- Primary completion
- 2022-12-29
- Completion
- 2023-11-29
Publications
- Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan;16(1):339-352. doi: 10.1007/s13555-025-01581-1. Epub 2025 Oct 31.
- Saeki H, Ohya Y, Baba N, Imamura T, Yokota D, Tsubouchi H. An Interim Report of a Phase 3, Long-Term, Open-Label Study to Evaluate Efficacy and Safety of Difamilast Ointment in Japanese Infants with Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2443-2455. doi: 10.1007/s13555-024-01236-7. Epub 2024 Jul 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Difamilast | Small molecule | 0.3 % | Topical |
| Subject | Difamilast | Small molecule | 1 % | Topical |