Crow's Feet Lines, Lateral Canthus Rhytides
Conditions
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).
Interventions
BIOLOGICALbotulinum toxin Type A (24 U)
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
BIOLOGICALbotulinum toxin Type A (12 U)
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
OTHERNormal Saline
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A (24U) 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. | 104 |
| Botulinum Toxin Type A (12U) 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. | 99 |
| Placebo/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 (24 U) 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). | 48 |
| Placebo/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 (12 U) 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). | 49 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 |
| Overall Study | Personal Reasons | 12 | 4 | 4 | 8 |
| Overall Study | Pregnancy | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A (24U) | Botulinum Toxin Type A (12U) | Placebo/Botulinum Toxin Type A (24 U) | Placebo/Botulinum Toxin Type A (12 U) | Total |
|---|---|---|---|---|---|
| Age, Customized ≤ 50 years | 53 participants | 58 participants | 28 participants | 30 participants | 169 participants |
| Age, Customized > 50 years | 51 participants | 41 participants | 20 participants | 19 participants | 131 participants |
| Sex: Female, Male Female | 84 Participants | 70 Participants | 36 Participants | 34 Participants | 224 Participants |
| Sex: Female, Male Male | 20 Participants | 29 Participants | 12 Participants | 15 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 151 | 39 / 143 | 5 / 97 |
| serious Total, serious adverse events | 3 / 151 | 2 / 143 | 2 / 97 |
Outcome results
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)
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.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (24U) | 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) | 68.3 percentage of participants |
| Botulinum Toxin Type A (12U) | 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) | 56.6 percentage of participants |
| Placebo | 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) | 8.2 percentage of participants |
Secondary
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.
Time frame: Day 30
Population: Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (24U) | 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 | 61.6 percentage of participants |
| Botulinum Toxin Type A (12U) | 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 | 43.6 percentage of participants |
| Placebo | 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 | 17.3 percentage of participants |
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
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.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (24U) | 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 | 49.0 percentage of participants |
| Botulinum Toxin Type A (12U) | 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 | 39.4 percentage of participants |
| Placebo | 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 | 1.0 percentage of participants |
Secondary
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.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (24U) | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 32.0 percentage of participants |
| Botulinum Toxin Type A (12U) | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 30.5 percentage of participants |
| Placebo | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 7.6 percentage of participants |