Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
Overview
- Phase
- Phase 3
- Intervention
- onabotulinumtoxinA
- Conditions
- Lateral Canthus Rhytides
- Sponsor
- Allergan
- Enrollment
- 446
- Primary Endpoint
- Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
- Status
- Completed
- Last Updated
- 6 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 (Lateral Canthal Rhytides).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Moderate to severe Crow's Feet Lines
- •Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Exclusion Criteria
- •Current or previous botulinum toxin treatment of any serotype
- •Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
- •Oral retinoid therapy within 1 year
- •Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Arms & Interventions
onabotulinumtoxinA
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
Intervention: onabotulinumtoxinA
placebo (normal saline)
normal saline injected into bilateral Crow's Feet Line areas on Day 1.
Intervention: normal saline
Outcomes
Primary Outcomes
Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
Time Frame: Baseline, Day 30
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.
Secondary Outcomes
- Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile(Baseline, Day 30)
- Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest(Baseline, Day 30)
- Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score(Day 30)
- Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline(Baseline, Day 30)
- Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30(Baseline, Day 30)
- Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30(Baseline, Day 30)
- Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30(Baseline, Day 30)
- Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines(Day 30)