Crow's Feet Lines, Lateral Canthus Rhytides
Conditions
Brief summary
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
Interventions
BIOLOGICALonabotulinumtoxinA
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1
DRUGnormal saline
Injected into bilateral Crow's Feet Line areas on Day 1
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe Crow's Feet Lines * Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Exclusion criteria
* Current or previous botulinum toxin treatment of any serotype * Facial laser or light treatment, microdermabrasion or superficial peels within 3 months * Oral retinoid therapy within 1 year * Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery) * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile | Baseline, Day 30 | The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile | Baseline, 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: 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 With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest | Baseline, Day 30 | The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 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. |
| Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score | Day 30 | Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 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. Lower scores indicate improvement. |
| Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 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: 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. |
| Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | Baseline, Day 30 | The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: When I look in the mirror, my facial lines make me look older than I want to look. 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). |
| Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | Baseline, Day 30 | The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: My facial lines make me look less attractive than I want to look. 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). |
| Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | Baseline, Day 30 | The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: My facial lines make me look tired 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). |
| Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline | Baseline, Day 30 | Participants were considered to judge themselves 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
Belgium, Canada, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| onabotulinumtoxinA 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1. | 222 |
| Placebo (Normal Saline) normal saline injected into bilateral Crow's Feet Line areas on Day 1. | 224 |
| Total | 446 |
Baseline characteristics
| Characteristic | onabotulinumtoxinA | Placebo (Normal Saline) | Total |
|---|---|---|---|
| Age, Customized 45 to 65 Years | 135 Participants | 118 Participants | 253 Participants |
| Age, Customized < 45 Years | 82 Participants | 101 Participants | 183 Participants |
| Age, Customized > 65 Years | 5 Participants | 5 Participants | 10 Participants |
| CFL Severity as Assessed by Investigator Moderate | 109 Participants | 112 Participants | 221 Participants |
| CFL Severity as Assessed by Investigator No data available | 1 Participants | 1 Participants | 2 Participants |
| CFL Severity as Assessed by Investigator Severe | 112 Participants | 111 Participants | 223 Participants |
| Sex: Female, Male Female | 193 Participants | 192 Participants | 385 Participants |
| Sex: Female, Male Male | 29 Participants | 32 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 220 | 0 / 224 |
| serious Total, serious adverse events | 6 / 220 | 3 / 224 |
Outcome results
Primary
Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile | 25.7 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile | 1.3 Percentage of participants |
Secondary
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 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 randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 66.7 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 6.7 Percentage of participants |
Secondary
Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline
Participants were considered to judge themselves 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: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline | 45.4 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline | 10.8 Percentage of participants |
Secondary
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile
The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 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: Baseline, Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile | 87.4 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile | 12.1 Percentage of participants |
Secondary
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest
The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 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: Baseline, Day 30
Population: Intent-to-treat participants included all randomized participants. Only participants who were rated at least mild at Baseline are included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest | 67.3 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest | 13.5 Percentage of participants |
Secondary
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: When I look in the mirror, my facial lines make me look older than I want to look. 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Time frame: Baseline, Day 30
Population: Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | 70.0 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | 28.4 Percentage of participants |
Secondary
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: My facial lines make me look less attractive than I want to look. 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Time frame: Baseline, Day 30
Population: Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | 66.8 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | 22.8 Percentage of participants |
Secondary
Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: My facial lines make me look tired 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 is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Time frame: Baseline, Day 30
Population: Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 3 were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA | Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | 55.8 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | 16.3 Percentage of participants |
Secondary
Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score
Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 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. Lower scores indicate improvement.
Time frame: Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| onabotulinumtoxinA | Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score | 2.2 Score on a scale | Standard Deviation 1.06 |
| Placebo (Normal Saline) | Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score | 3.8 Score on a scale | Standard Deviation 0.67 |