Conditions: Facial Rhytides Crow's Feet Lines Glabellar Lines
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 917
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Interventions: intervention 1: onabotulinumtoxinA 24 U intervention 2: onabotulinumtoxinA 44 U intervention 3: normal saline
Intervention descriptions: intervention 1: 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. intervention 2: 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 intervention 3: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.

Protocol document: