Phase 3
Completed N=41
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Atopic Dermatitis (AD)
Source: ClinicalTrials.gov NCT05372653 ↗
Enrolled (actual)
41
Serious AEs
2.9%
Results posted
Mar 2025
Primary outcomePrimary: Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) — 56.10 Percentage of perticipants
◆ Published Evidence
Emerging
2citations · ~2 / year
A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.
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
Linked Publications (2)
-
A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) |
56.10 | — |
| SECONDARY Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) |
82.93 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
- Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
- Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria
-Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Data sourced from ClinicalTrials.gov (NCT05372653) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.