Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03954444 | A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" | PHASE3 | COMPLETED | 1,105 | — | — | Apr 15, 2019 | Feb 27, 2020 | Jun 23, 2021 | 1 | United States |
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).
| Arm | Type | Description |
|---|---|---|
| Oxymetazoline hydrochloride Cream, 1% | ACTIVE_COMPARATOR | Oxymetazoline hydrochloride cream, 1% |
| RHOFADE Cream, 1% | ACTIVE_COMPARATOR | RHOFADE Cream, 1% |
| Vehicle Cream | PLACEBO_COMPARATOR | Vehicle cream |
| Name | Type | Description |
|---|---|---|
| Oxymetazoline Hydrochloride | DRUG | Test Comparator |
| Rhofade Cream, 1% | DRUG | Reference Comparator |
| Placebo | DRUG | Placebo Comparator |
Inclusion Criteria: * (1) Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form, (or assent in applicable states/countries). In addition, study subjects must sign a HIPAA authorization, if applicable. * (2) Healthy male or ...