Phase 3
N=41
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Atopic Dermatitis (AD)
Bottom Line
View on ClinicalTrials.gov: NCT05372653 ↗Enrolled (actual)
41
Serious AEs
2.9%
Results posted
Mar 2025
Primary outcome: 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 Percentage of perticipants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPA-15406 (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2022
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 | — |
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
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). 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.