Crow's Feet Lines, Facial Rhytides, Glabellar Lines
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 and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.
Interventions
DRUGnormal saline
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
BIOLOGICALonabotulinumtoxinA 44 U
44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
BIOLOGICALonabotulinumtoxinA 24 U
24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
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
* Successfully completed Study 191622-099
Exclusion criteria
* Known immunization or hypersensitivity to botulinum toxin of any serotype * Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment) * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Anticipated need for surgery or hospitalization during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator 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. |
Countries
Canada, France, Germany, United States
Participant flow
Pre-assignment details
Extension study for patients who participated in study 191622-099
Participants by arm
| Arm | Count |
|---|---|
| onabotulinumtoxinA 44U 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 361 |
| onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 227 |
| Placebo (Normal Saline) Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study. | 96 |
| Total | 684 |
Baseline characteristics
| Characteristic | Total | onabotulinumtoxinA 44U | onabotulinumtoxinA 24U | Placebo (Normal Saline) |
|---|---|---|---|---|
| Age, Customized 45 to 65 Years | 448 Participants | 241 Participants | 148 Participants | 59 Participants |
| Age, Customized <45 Years | 206 Participants | 105 Participants | 68 Participants | 33 Participants |
| Age, Customized >65 Years | 30 Participants | 15 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Female | 598 Participants | 315 Participants | 203 Participants | 80 Participants |
| Sex: Female, Male Male | 86 Participants | 46 Participants | 24 Participants | 16 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 | 44 / 349 | 23 / 223 | 15 / 95 |
| serious Total, serious adverse events | 6 / 349 | 1 / 223 | 1 / 95 |
Outcome results
Primary
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator 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: Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| onabotulinumtoxinA 44U | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 63.6 Percentage of participants |
| onabotulinumtoxinA 24U | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 56.5 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | 1.1 Percentage of participants |