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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01189760 | Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines | PHASE3 | COMPLETED | 917 | — | — | Sep 1, 2010 | Sep 1, 2011 | Apr 16, 2019 | 4 | United States, Canada +2 |
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. 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 and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
| Arm | Type | Description |
|---|---|---|
| onabotulinumtoxinA 44U | EXPERIMENTAL | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| onabotulinumtoxinA 24U | OTHER | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| placebo (normal saline) | PLACEBO_COMPARATOR | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| Name | Type | Description |
|---|---|---|
| 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 will receive two treatments 4 months apart. |
| 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 will receive two treatments 4 months apart |
| normal saline | DRUG | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. |
Inclusion Criteria: * Moderate to severe Crow's Feet Lines and Frown Lines * Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK) Exclusion Criteria: * Current or previous botulinum toxin treatment of any serotype * Diagnosis of myasthenia...