BOTOX® in the Treatment of Crow's Feet Lines in Japan

Study Overview
=================
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).

Conditions
-----------------
Lateral Canthus Rhytides, Crow's Feet Lines

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A (24 U)
* Biological: botulinum toxin Type A (12 U)
* Other: Normal Saline


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin Type A (24U)<br>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. | Biological: botulinum toxin Type A (24 U)<br>* 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.<br>* Other names: BOTOX®;|
| Experimental: Botulinum toxin Type A (12U)<br>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. | Biological: botulinum toxin Type A (12 U)<br>* 12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.<br>* Other names: BOTOX®;|
| Other: Placebo/Botulinum toxin Type A (24U)<br>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). | Biological: botulinum toxin Type A (24 U)<br>* 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.<br>* Other names: BOTOX®;Other: Normal Saline<br>* Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.<br>|
| Other: Placebo/Botulinum toxin Type A (12U)<br>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). | Biological: botulinum toxin Type A (12 U)<br>* 12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.<br>* Other names: BOTOX®;Other: Normal Saline<br>* Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Day 30 | 
| 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 | 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. | Day 30 | 
| Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 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. | Day 30 |