Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Overview
- Phase
- Phase 3
- Intervention
- normal saline
- Conditions
- Facial Rhytides
- Sponsor
- Allergan
- Enrollment
- 684
- Primary Endpoint
- Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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) for patients who successfully completed Study 191622-099.
Investigators
Eligibility Criteria
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 myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- •Anticipated need for surgery or hospitalization during the study
Arms & Interventions
onabotulinumtoxinA 24U
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.
Intervention: normal saline
onabotulinumtoxinA 24U
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.
Intervention: onabotulinumtoxinA 24 U
placebo (normal saline)
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.
Intervention: normal saline
onabotulinumtoxinA 44U
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.
Intervention: onabotulinumtoxinA 44 U
Outcomes
Primary Outcomes
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
Time Frame: 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. The percentage of participants with a score of none or mild at Day 30 is reported.