Phase 2
Completed N=121
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02068352 ↗Enrolled (actual)
121
Serious AEs
3.3%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] — 14.63; 20.93; 2.70; 15.00 percentage of participants — p=0.0690
Summary
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] |
14.63; 20.93; 2.70; 15.00; 20.93; 2.70 | 0.0690 |
| SECONDARY Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis] |
-0.56; -0.55; -0.09 | 0.0128 sig |
| SECONDARY Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis] |
-0.54; -0.54; -0.04 | 0.0048 sig |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
26.8; 11.6; 18.9; 58.5; 41.9; 54.1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants 10-70 years of age
- Diagnosis of AD
- History of AD for at least 3 years
- AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
- Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)
Exclusion Criteria
- Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
- Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.
Data sourced from ClinicalTrials.gov (NCT02068352). 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.