Phase 3
N=446
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
Lateral Canthus Rhytides · Crow's Feet Lines
Bottom Line
View on ClinicalTrials.gov: NCT01189747 ↗Enrolled (actual)
446
Serious AEs
2.0%
Results posted
Dec 2013
Primary outcome: Primary: Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile — 25.7; 1.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- onabotulinumtoxinA (Biological); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile |
25.7; 1.3 | — |
| SECONDARY 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 |
66.7; 6.7 | — |
| SECONDARY 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 |
87.4; 12.1 | — |
| SECONDARY 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 |
67.3; 13.5 | — |
| SECONDARY Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score |
2.2; 3.8 | — |
| SECONDARY Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline |
45.4; 10.8 | — |
| SECONDARY Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 |
70.0; 28.4 | — |
| SECONDARY Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 |
66.8; 22.8 | — |
| SECONDARY Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 |
55.8; 16.3 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01189747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.