BOTOX® in the Treatment of Crow's Feet Lines in Japan
- Conditions
- Lateral Canthus RhytidesCrow's Feet Lines
- Interventions
- Biological: botulinum toxin Type A (24 U)Biological: botulinum toxin Type A (12 U)Other: Normal Saline
- Registration Number
- NCT01797081
- Lead Sponsor
- Allergan
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
-Moderate to severe Crow's Feet Lines
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo/Botulinum toxin Type A (12U) Normal Saline Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). Botulinum toxin Type A (24U) botulinum toxin Type A (24 U) 24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. Placebo/Botulinum toxin Type A (24U) botulinum toxin Type A (24 U) Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). Placebo/Botulinum toxin Type A (12U) botulinum toxin Type A (12 U) Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). Botulinum toxin Type A (12U) botulinum toxin Type A (12 U) 12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. Placebo/Botulinum toxin Type A (24U) Normal Saline Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
- Primary Outcome Measures
Name Time Method 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) Day 30 The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
- Secondary Outcome Measures
Name Time Method 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 Day 30 Participants rated the change in their Crow's Feet Lines using the Subject's Global Assessment of Change in Crow's Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline Day 30 Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30.
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 Day 30 The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.