BOTOX® in the Treatment of Upper Facial Lines in Japan

Study Overview
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Brief Summary
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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).

Conditions
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Upper Facial Rhytides, Crow's Feet Lines, Glabellar Lines, Frown Lines

Intervention / Treatment
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* Biological: botulinum toxin Type A (44U)
* Biological: botulinum toxin Type A (32U)


Participation Criteria
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Eligibility Criteria
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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)

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 (44U)<br>44 units (U) botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. | Biological: botulinum toxin Type A (44U)<br>* 44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.<br>* Other names: BOTOX®;|
| Experimental: Botulinum toxin Type A (32U)<br>32 units (U) botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. | Biological: botulinum toxin Type A (32U)<br>* 32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.<br>* Other names: BOTOX®;|

What is the study measuring?
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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 participant'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 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) | Participants rated the change in their Crow's Feet Lines using the 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 at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported. | Day 30 | 
| Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : When I look in the mirror, my facial lines make me look older than I want to look score. | Baseline, Day 30 | 
| Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: My facial lines make me look less attractive than I want to look score. | Baseline, Day 30 | 
| Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: My facial lines make me look tired score. | Baseline, 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. | Baseline, Day 30 | 
| Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported. | Day 30 |