Phase 3
N=917
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Facial Rhytides · Crow's Feet Lines · Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT01189760 ↗Enrolled (actual)
917
Serious AEs
2.1%
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 — 21.3; 20.6; 0.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- onabotulinumtoxinA 24 U (Biological); onabotulinumtoxinA 44 U (Biological); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 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 |
21.3; 20.6; 0.0 | — |
| SECONDARY 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 |
59.0; 54.9; 3.3 | — |
| 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 |
87.9; 78.1; 10.1 | — |
| 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 |
75.1; 61.3; 13.4 | — |
| SECONDARY Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score |
2.3; 2.5; 3.8 | — |
| SECONDARY Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline |
50.6; 33.6; 9.1 | — |
| SECONDARY Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 |
69.9; 54.4; 24.6 | — |
| SECONDARY Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 |
61.7; 48.6; 18.6 | — |
| SECONDARY Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 |
58.1; 40.7; 14.9 | — |
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)
Eligibility Criteria
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 gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Oral retinoid therapy within one year
Data sourced from ClinicalTrials.gov (NCT01189760). 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.