Platysma Prominence
Conditions
Keywords
Platysma Prominence, OnabotulinumtoxinA, BOTOX
Brief summary
The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study in the United States and Canada. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.
Interventions
DRUGOnabotulinumtoxinA
Injection
DRUGPlacebo
Saline Injection
Sponsors
AbbVie
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
* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures * Are willing and able to comply with procedures required in the protocol * Adult male or female, at least 18 years old at the time of signing the informed consent * Good health as determined by medical history, physical examination, vital signs, and investigator's judgment
Exclusion criteria
* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) * Anticipated need for surgery or overnight hospitalization during the study * Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study * Known immunization or hypersensitivity to any botulinum toxin serotype * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months * Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable) * Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Enrollment to Day 120 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. |
| Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14 | Day 14 | The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. |
| Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14 | Day 14 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. |
| Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14 | Day 14 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). |
| Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | Day 14 | The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact. |
| Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14, 30, 60, 90, and 120 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. |
| Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14, 30, 60, 90, and 120 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. |
| Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14, 30, 60, 90, and 120 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. |
| Percentage of Participants With Responses of Satisfied or Very Satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | Day 14 | The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied). |
| Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14 | Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). |
| Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Days 30, 60, and 90 | The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face. |
| Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14 | Day 14 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. |
| Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14, 30, 60, 90, and 120 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. |
| Percentage of Participants With Responses of Satisfied or Very Satisfied on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | Day 14 | The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied). |
| Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14 | Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 408 participants were enrolled and randomized in this study (199 subjects to BOTOX; 209 to placebo). A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
Pre-assignment details
The ITT Population included all randomized participants (N=408); the modified ITT Population included all randomized participants with a baseline summary score ≥ 19 on the ANLFQ: Impacts questionnaire (N=367). The Safety Analysis Set included all participants who were treated with at least 1 dose of study drug (N=408).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was injected into the platysma muscle on Day 1 | 209 |
| BOTOX BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 | 199 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo | BOTOX | Total |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 9.75 | 49.5 years STANDARD_DEVIATION 10.23 | 49.7 years STANDARD_DEVIATION 9.98 |
| Age, Customized 40 - 54 years | 106 Participants | 103 Participants | 209 Participants |
| Age, Customized < 40 years | 32 Participants | 32 Participants | 64 Participants |
| Age, Customized 55 - 64 years | 61 Participants | 53 Participants | 114 Participants |
| Age, Customized ≥ 65 years | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 33 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 193 Participants | 166 Participants | 359 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 186 Participants | 180 Participants | 366 Participants |
| Sex: Female, Male Female | 197 Participants | 187 Participants | 384 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 199 |
| other Total, other adverse events | 11 / 209 | 11 / 199 |
| serious Total, serious adverse events | 3 / 209 | 2 / 199 |
Outcome results
Primary
Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14 | 3.9 percentage of participants |
| BOTOX | Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14 | 43.8 percentage of participants |
p-value: <0.000195% CI: [32, 47.7]Cochran-Mantel-Haenszel
Primary
Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14 | 3.9 percentage of participants |
| BOTOX | Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14 | 45.6 percentage of participants |
p-value: <0.000195% CI: [33.7, 49.6]Cochran-Mantel-Haenszel
Primary
Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Time frame: Day 14
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14 | 1.9 percentage of participants |
| BOTOX | Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14 | 32.3 percentage of participants |
p-value: <0.000195% CI: [23.5, 37.2]Cochran-Mantel-Haenszel
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Time frame: Enrollment to Day 120
Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events | 45 Participants |
| BOTOX | Number of Participants With Adverse Events | 47 Participants |
Secondary
Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90
The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.
Time frame: Days 30, 60, and 90
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 30 | -2.8 score on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 60 | -2.7 score on a scale | Standard Error 0.43 |
| Placebo | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 90 | -2.4 score on a scale | Standard Error 0.45 |
| BOTOX | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 30 | -8.4 score on a scale | Standard Error 0.44 |
| BOTOX | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 60 | -7.7 score on a scale | Standard Error 0.43 |
| BOTOX | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | Day 90 | -6.3 score on a scale | Standard Error 0.44 |
Comparison: Day 30p-value: <0.000195% CI: [-6.7, -4.5]ANCOVA
Comparison: Day 60p-value: <0.000195% CI: [-6, -3.9]ANCOVA
Comparison: Day 90p-value: <0.000195% CI: [-4.9, -2.8]ANCOVA
Secondary
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14
The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -2.1 score on a scale | Standard Error 0.44 |
| BOTOX | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -7.8 score on a scale | Standard Error 0.43 |
p-value: <0.000195% CI: [-6.8, -4.6]ANCOVA
Secondary
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14
The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.
Time frame: Day 14
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -1.7 score on a scale | Standard Error 0.4 |
| BOTOX | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -7.4 score on a scale | Standard Error 0.4 |
p-value: <0.000195% CI: [-6.7, -4.7]ANCOVA
Secondary
Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14 | 5.2 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14 | 51.4 percentage of participants |
p-value: <0.000196% CI: [38.1, 54.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Time frame: Day 14, 30, 60, 90, and 120
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 21.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 15.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 6.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 19.8 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 21.5 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 80.1 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 58.5 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 43.6 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 75.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Time frame: Day 14, 30, 60, 90, and 120
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 23.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 20.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 22.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 23.2 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 69.7 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 80.5 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 78.2 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 49.4 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 25.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Time frame: Day 14, 30, 60, 90, and 120
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 6.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 6.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 4.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 1.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 5.8 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 3.7 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 56.9 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 23.8 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 44.1 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 11.3 percentage of participants |
Secondary
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Time frame: Day 14, 30, 60, 90, and 120
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 7.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 1.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 6.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 4.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 5.1 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 90 | 14.7 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 14 | 51.7 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 30 | 45.1 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 60 | 33.4 percentage of participants |
| BOTOX | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | Day 120 | 5.4 percentage of participants |
Secondary
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Time frame: Day 14
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | 7.4 percentage of participants |
| BOTOX | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | 52.1 percentage of participants |
p-value: <0.000195% CI: [36.8, 52.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | 5.4 percentage of participants |
| BOTOX | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | 50.6 percentage of participants |
p-value: <0.000195% CI: [37.1, 53.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14
The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14 | 11.3 percentage of participants |
| BOTOX | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14 | 51.5 percentage of participants |
p-value: <0.000195% CI: [31.3, 49]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14
The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Time frame: Day 14
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14 | 14.7 percentage of participants |
| BOTOX | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14 | 53.9 percentage of participants |
p-value: <0.000195% CI: [30.5, 47.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Responses of Satisfied or Very Satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
Time frame: Day 14
Population: The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of Satisfied or Very Satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | 11.7 percentage of participants |
| BOTOX | Percentage of Participants With Responses of Satisfied or Very Satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | 63.6 percentage of participants |
p-value: <0.000195% CI: [43.3, 60.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Responses of Satisfied or Very Satisfied on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
Time frame: Day 14
Population: The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Responses of Satisfied or Very Satisfied on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | 11.1 percentage of participants |
| BOTOX | Percentage of Participants With Responses of Satisfied or Very Satisfied on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | 65.9 percentage of participants |
p-value: <0.000195% CI: [46.8, 62.8]Cochran-Mantel-Haenszel