Phase 3
N=417
BOTOX® in the Treatment of Crow's Feet Lines in China
Lateral Canthal Lines · Crow's Feet Lines
Bottom Line
View on ClinicalTrials.gov: NCT02195687 ↗Enrolled (actual)
417
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Subjects 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) — 63.9; 5.0 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (Biological); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects 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) |
63.9; 5.0 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A |
60.1; 5.4 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A |
85.1; 12.9 | — |
| SECONDARY Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL) |
54.4; 3.0 | — |
| SECONDARY Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire |
53.9; 14.7 | — |
| SECONDARY Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) |
60.8; 5.9 | — |
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
Eligibility Criteria
Inclusion Criteria
-Moderate to severe Crow's Feet Lines.
Exclusion Criteria
- Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
- Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
- Any medium-depth or deep facial peels within 5 years
- Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.
Data sourced from ClinicalTrials.gov (NCT02195687). 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.