Phase 3
Completed N=366
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03961529 ↗Enrolled (actual)
366
Serious AEs
0.8%
Results posted
Nov 2021
Primary outcomePrimary: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) — 120; 131; 47 Participants
◆ Published Evidence
Established
22citations · ~6 / year
Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study.
Summary
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
Linked Publications
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Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) |
120; 131; 47 | — |
| SECONDARY Responder Rate of Investigator's Global Assessment (IGA) |
34.94; 52.78; 51.79 | — |
| SECONDARY Responder Rate of Eczema Area and Severity Index 75 (EASI 75) |
55.42; 77.08; 64.29 | — |
Eligibility Criteria
Inclusion Criteria
- Age: At least 2 years (at time of obtaining informed consent)
- Diagnosis of AD based on the Japanese Dermatological Association's criteria
- Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) 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 (NCT03961529) 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.