Crow's Feet Lines, Lateral Canthal Lines
Conditions
Brief summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
DRUGNormal Saline
Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Moderate to severe Crow's Feet Lines.
Exclusion criteria
* Current or previous treatment with botulinum toxin of any serotype for any condition within the last year * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis * Facial laser or light treatment, microdermabrasion or chemical peels within 3 months * Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year * Any medium-depth or deep facial peels within 5 years * Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects 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 subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A | Day 30 | The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted. |
| Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A | Day 30 | The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted. |
| Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL) | Day 30 | Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted. |
| Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire | Baseline, Day 30 | Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted. |
| Percentage of Subjects Achieving None or Mild on the Subject'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 subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported. |
Countries
China
Participant flow
Pre-assignment details
The participant flow reflects the Safety Population, which includes all randomized subjects who received at least 1 study drug injection.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1. | 316 |
| Placebo Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1. | 101 |
| Total | 417 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Personal Reasons | 1 | 1 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 46.3 Years STANDARD_DEVIATION 9.64 | 46.6 Years STANDARD_DEVIATION 9.39 | 46.4 Years STANDARD_DEVIATION 9.57 |
| Sex: Female, Male Female | 273 Participants | 87 Participants | 360 Participants |
| Sex: Female, Male Male | 43 Participants | 14 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 316 | 0 / 101 |
| serious Total, serious adverse events | 0 / 316 | 0 / 101 |
Outcome results
Primary
Percentage of Subjects 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 subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Time frame: Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects 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) | 63.9 Percentage of Subjects |
| Placebo | Percentage of Subjects 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) | 5.0 Percentage of Subjects |
Secondary
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Time frame: Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 60.8 Percentage of Subjects |
| Placebo | Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 5.9 Percentage of Subjects |
Secondary
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
Time frame: Baseline, Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire | 53.9 Percentage of Subjects |
| Placebo | Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire | 14.7 Percentage of Subjects |
Secondary
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
Time frame: Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL) | 54.4 Percentage of Subjects |
| Placebo | Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL) | 3.0 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
Time frame: Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A | 85.1 Percentage of Subjects |
| Placebo | Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A | 12.9 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
Time frame: Day 30
Population: Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A | 60.1 Percentage of Subjects |
| Placebo | Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A | 5.4 Percentage of Subjects |