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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01224015 | Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines | PHASE3 | COMPLETED | 684 | — | — | May 1, 2011 | Feb 1, 2012 | Feb 25, 2014 | 4 | United States, Canada +2 |
The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
| Arm | Type | Description |
|---|---|---|
| onabotulinumtoxinA 24U | OTHER | 24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| placebo (normal saline) | PLACEBO_COMPARATOR | Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 44U | EXPERIMENTAL | 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| Name | Type | Description |
|---|---|---|
| normal saline | DRUG | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 44 U | BIOLOGICAL | 44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 24 U | BIOLOGICAL | 24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
Inclusion Criteria: * Successfully completed Study 191622-099 Exclusion Criteria: * Known immunization or hypersensitivity to botulinum toxin of any serotype * Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment) * Diagnosis of myasthen...