Phase 3
N=300
BOTOX® in the Treatment of Crow's Feet Lines in Japan
Lateral Canthus Rhytides · Crow's Feet Lines
Bottom Line
View on ClinicalTrials.gov: NCT01797081 ↗Enrolled (actual)
300
Serious AEs
1.8%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) — 68.3; 56.6; 8.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (24 U) (Biological); botulinum toxin Type A (12 U) (Biological); Normal Saline (Other)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) |
68.3; 56.6; 8.2 | — |
| SECONDARY Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A |
61.6; 43.6; 17.3 | — |
| SECONDARY Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines |
49.0; 39.4; 1.0 | — |
| SECONDARY Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline |
32.0; 30.5; 7.6 | — |
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
Eligibility Criteria
Inclusion Criteria
-Moderate to severe Crow's Feet Lines
Exclusion Criteria
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
- Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
- Medium-depth or deep facial peels within 5 years
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Data sourced from ClinicalTrials.gov (NCT01797081). 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.