Phase 3
N=101
BOTOX® in the Treatment of Upper Facial Lines in Japan
Upper Facial Rhytides · Crow's Feet Lines · Glabellar Lines · Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT01797094 ↗Enrolled (actual)
101
Serious AEs
5.0%
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) — 89.6; 84.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (44U) (Biological); botulinum toxin Type A (32U) (Biological)
- 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) |
89.6; 84.9 | — |
| 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 (SGA-CFL) |
87.6; 77.4 | — |
| SECONDARY Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 |
84.8; 88.0 | — |
| SECONDARY Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 |
73.9; 72.5 | — |
| SECONDARY Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 |
86.0; 69.4 | — |
| SECONDARY Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline |
54.3; 56.9 | — |
| SECONDARY Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire |
81.3; 81.1 | — |
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
Eligibility Criteria
Inclusion Criteria
-Moderate to severe Crow's Feet Lines and Frown 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 (NCT01797094). 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.