Trial Outcomes & Findings for A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence (NCT NCT04949399)
NCT ID: NCT04949399
Last Updated: 2024-11-20
Results Overview
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.
COMPLETED
PHASE3
408 participants
Enrollment to Day 120
2024-11-20
Participant Flow
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.
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).
Participant milestones
| Measure |
Placebo
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
199
|
|
Overall Study
COMPLETED
|
196
|
190
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Baseline characteristics by cohort
| Measure |
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
Total
n=408 Participants
Total of all reporting groups
|
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 10.23 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Age, Customized
< 40 years
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
32 Participants
n=5 Participants
|
|
Age, Customized
40 - 54 years
|
103 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
106 Participants
n=5 Participants
|
|
Age, Customized
55 - 64 years
|
53 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
61 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
180 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
186 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to Day 120Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
Number of Participants With Adverse Events
|
45 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 0.1 to 3.8
|
32.3 percentage of participants
Interval 25.7 to 38.9
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 1.1 to 6.8
|
43.8 percentage of participants
Interval 36.4 to 51.1
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 1.1 to 6.8
|
45.6 percentage of participants
Interval 38.2 to 52.9
|
SECONDARY outcome
Timeframe: Day 14, 30, 60, 90, and 120Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 2.5 to 9.2
|
56.9 percentage of participants
Interval 49.9 to 63.9
|
|
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
Interval 3.3 to 10.2
|
44.1 percentage of participants
Interval 37.1 to 51.0
|
|
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
Interval 3.2 to 10.2
|
23.8 percentage of participants
Interval 17.7 to 29.9
|
|
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
Interval 1.4 to 7.2
|
11.3 percentage of participants
Interval 6.8 to 15.8
|
|
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
Interval 0.0 to 3.6
|
3.7 percentage of participants
Interval 1.0 to 6.4
|
SECONDARY outcome
Timeframe: Day 14, 30, 60, 90, and 120Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 2.1 to 8.2
|
51.7 percentage of participants
Interval 44.7 to 58.8
|
|
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
Interval 3.5 to 10.7
|
45.1 percentage of participants
Interval 38.1 to 52.1
|
|
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
Interval 3.0 to 9.8
|
33.4 percentage of participants
Interval 26.7 to 40.0
|
|
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
Interval 1.5 to 7.7
|
14.7 percentage of participants
Interval 9.7 to 19.7
|
|
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
Interval 0.0 to 3.4
|
5.4 percentage of participants
Interval 2.2 to 8.6
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 6.7 to 15.6
|
65.9 percentage of participants
Interval 59.2 to 72.6
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 9.6 to 19.8
|
53.9 percentage of participants
Interval 46.9 to 60.8
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 3.8 to 11.1
|
52.1 percentage of participants
Interval 45.1 to 59.1
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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 0.40
|
-7.4 score on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Day 14, 30, 60, 90, and 120Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 15.7 to 27.1
|
75.0 percentage of participants
Interval 68.9 to 81.1
|
|
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
Interval 9.9 to 20.1
|
43.6 percentage of participants
Interval 36.5 to 50.7
|
|
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
Interval 13.5 to 24.5
|
80.1 percentage of participants
Interval 74.5 to 85.7
|
|
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
Interval 14.2 to 25.4
|
58.5 percentage of participants
Interval 51.5 to 65.5
|
|
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
Interval 2.8 to 9.9
|
21.5 percentage of participants
Interval 15.7 to 27.3
|
SECONDARY outcome
Timeframe: Day 14, 30, 60, 90, and 120Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 16.8 to 28.3
|
69.7 percentage of participants
Interval 63.3 to 76.2
|
|
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
Interval 9.6 to 19.6
|
25.8 percentage of participants
Interval 19.6 to 32.0
|
|
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
Interval 17.3 to 29.1
|
80.5 percentage of participants
Interval 74.9 to 86.1
|
|
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
Interval 17.4 to 29.1
|
78.2 percentage of participants
Interval 72.5 to 84.0
|
|
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
Interval 14.7 to 26.1
|
49.4 percentage of participants
Interval 42.2 to 56.6
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 1.9 to 8.5
|
51.4 percentage of participants
Interval 44.0 to 58.7
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 6.9 to 16.5
|
63.6 percentage of participants
Interval 56.5 to 70.8
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 6.5 to 16.2
|
51.5 percentage of participants
Interval 44.1 to 58.8
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
Interval 2.1 to 8.8
|
50.6 percentage of participants
Interval 43.3 to 58.0
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
|
-7.8 score on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Days 30, 60, and 90Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=181 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
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
|
-8.4 score on a scale
Standard Error 0.44
|
|
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
|
-7.7 score on a scale
Standard Error 0.43
|
|
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
|
-6.3 score on a scale
Standard Error 0.44
|
Adverse Events
Placebo
BOTOX
Serious adverse events
| Measure |
Placebo
n=209 participants at risk
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 participants at risk
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
Eye disorders
OPHTHALMIC VASCULAR THROMBOSIS
|
0.48%
1/209 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
0.00%
0/199 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/209 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
0.50%
1/199 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/209 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
0.50%
1/199 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.48%
1/209 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
0.00%
0/199 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.48%
1/209 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
0.00%
0/199 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
Other adverse events
| Measure |
Placebo
n=209 participants at risk
Placebo was injected into the platysma muscle on Day 1
|
BOTOX
n=199 participants at risk
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
|
|---|---|---|
|
General disorders
INJECTION SITE BRUISING
|
2.4%
5/209 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
1.0%
2/199 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
|
Infections and infestations
COVID-19
|
2.9%
6/209 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
4.5%
9/199 • Number of events 9 • All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER