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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02261493 | A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides | PHASE3 | COMPLETED | 787 | — | — | Oct 27, 2014 | Apr 20, 2016 | Jul 25, 2017 | 24 | United States, Belgium +2 |
The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.
| Arm | Type | Description |
|---|---|---|
| OnabotulinumtoxinA Dose A | EXPERIMENTAL | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| OnabotulinumtoxinA Dose B | EXPERIMENTAL | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| Placebo followed by OnabotulinumtoxinA Dose A | PLACEBO_COMPARATOR | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA | BIOLOGICAL | OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments. |
| Normal Saline | DRUG | Placebo (normal saline) injected into the protocol-specified areas on Day 1. |
Inclusion Criteria: * Moderate to severe forehead lines, glabellar lines, and crow's feet lines * Willing to have facial photos taken Exclusion Criteria: * Prior exposure to botulinum toxin of any serotype for any indication * Anticipated need for treatment with botulinum toxin of any serotype fo...