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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05320393 | Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines | PHASE2 | COMPLETED | 154 | — | — | Mar 30, 2022 | May 22, 2023 | Sep 4, 2024 | 1 | United States |
Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.
| Arm | Type | Description |
|---|---|---|
| Study Drug | EXPERIMENTAL | 40U of PrabotulinumtoxinA-xvfs |
| OnabotulinumtoxinA | ACTIVE_COMPARATOR | 20U of OnabotulinumtoxinA |
| PrabotulinumtoxinA-xvfs | ACTIVE_COMPARATOR | 20U of PrabotulinumtoxinA-xvfs |
| Name | Type | Description |
|---|---|---|
| PrabotulinumtoxinA-Xvfs | DRUG | One treatment of 40 units |
| OnabotulinumtoxinA | DRUG | One treatment of 20 units |
Inclusion Criteria: * Outpatient, male or female of any race, 18 years of age or older. * Female subjects of childbearing potential must have a negative urine pregnancy test during Visits 1 (Screening) and Visit 2 (if applicable) and practice a reliable method of contraception for the duration of t...