Facial Rhytides
Conditions
Brief summary
This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).
Interventions
BIOLOGICALonabotulinumtoxinA
BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
DRUGNormal Saline
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Glabellar lines and crow's feet lines * No prior use of botulinum toxin therapy of any serotype for any reason
Exclusion criteria
* Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers * Planning a facial cosmetic procedure during the study period * Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis * Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) | Day 60 | Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 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 with responses mostly or very satisfied is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ | Day 90 | Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported. |
| Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ | Day 60 | Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. |
| Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Day 90 | Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported. |
| Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ | Day 60 | Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported. |
| Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ | Day 60 | Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 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. |
| Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | Day 90 | Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. |
| Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS | Day 30 | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported. |
| Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS | Baseline, Day 30 | The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported. |
| Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ | Day 90 | Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BOTOX® BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1. | 60 |
| Placebo Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1. | 57 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject Withdrawal | 1 | 0 |
Baseline characteristics
| Characteristic | BOTOX® | Placebo | Total |
|---|---|---|---|
| Age, Customized 45 - 65 years | 35 Participants | 33 Participants | 68 Participants |
| Age, Customized < 45 years | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Female | 48 Participants | 50 Participants | 98 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 63 | 4 / 62 |
| serious Total, serious adverse events | 1 / 63 | 0 / 62 |
Outcome results
Primary
Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Time frame: Day 60
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) | 81.7 Percentage of participants |
| Placebo | Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) | 0.0 Percentage of participants |
Secondary
Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Time frame: Day 90
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | 61.7 Percentage of participants |
| Placebo | Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | 0.0 Percentage of participants |
Secondary
Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ
Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 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 with responses mostly or very satisfied is reported.
Time frame: Day 90
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ | 65.0 Percentage of participants |
| Placebo | Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ | 0.0 Percentage of participants |
Secondary
Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ
Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 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.
Time frame: Day 60
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ | 81.7 Percentage of participants |
| Placebo | Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ | 0.0 Percentage of participants |
Secondary
Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ
Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.
Time frame: Day 60
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ | 86.7 Percentage of participants |
| Placebo | Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ | 15.8 Percentage of participants |
Secondary
Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ
Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.
Time frame: Day 60
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ | 88.3 Percentage of participants |
| Placebo | Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ | 14.0 Percentage of participants |
Secondary
Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
Time frame: Day 90
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | 78.3 Percentage of participants |
| Placebo | Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ | 31.6 Percentage of participants |
Secondary
Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ
Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
Time frame: Day 90
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ | 78.3 Percentage of participants |
| Placebo | Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ | 36.8 Percentage of participants |
Secondary
Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS
The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.
Time frame: Day 30
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS | 83.3 Percentage of participants |
| Placebo | Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS | 1.8 Percentage of participants |
Secondary
Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS
The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.
Time frame: Baseline, Day 30
Population: Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS | 86.7 Percentage of participants |
| Placebo | Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS | 8.8 Percentage of participants |