Trial Outcomes & Findings for BOTOX® for the Treatment of Platysma Prominence (NCT NCT03915067)
NCT ID: NCT03915067
Last Updated: 2023-05-03
Results Overview
The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
171 participants
Primary outcome timeframe
Day 14
Results posted on
2023-05-03
Participant Flow
Participant flow and all-cause mortality tables are based on all participants randomized on Day 1. Adverse events are reported for safety population, which included all participants who were administered study intervention.
Participant milestones
| Measure |
Placebo
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
59
|
55
|
|
Overall Study
Modified Intent-to-treat (mITT) Population
|
53
|
58
|
53
|
|
Overall Study
Safety Population
|
56
|
59
|
54
|
|
Overall Study
COMPLETED
|
47
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
|
Overall Study
Covid-19 Related Issues
|
2
|
4
|
4
|
|
Overall Study
Randomized With Incorrect C-APPS
|
1
|
0
|
0
|
Baseline Characteristics
BOTOX® for the Treatment of Platysma Prominence
Baseline characteristics by cohort
| Measure |
Placebo
n=53 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=58 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=53 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 9.59 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 9.16 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 9.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses.
The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=54 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)
|
12.0 percentage of participants
Interval 3.0 to 21.0
|
77.8 percentage of participants
Interval 66.7 to 88.9
|
88.2 percentage of participants
Interval 79.4 to 97.1
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to Day 120)Population: Safety population included all participants who were administered study intervention.
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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
|
13 Participants
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Safety population included all participants who were administered study intervention.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Pulse Rate at Baseline
|
73.0 beats per minute (beats/min)
Standard Deviation 10.77
|
74.4 beats per minute (beats/min)
Standard Deviation 9.77
|
73.6 beats per minute (beats/min)
Standard Deviation 10.66
|
PRIMARY outcome
Timeframe: Baseline; Day 7Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=49 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=46 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 7
|
1.0 beats/min
Standard Deviation 8.19
|
-0.5 beats/min
Standard Deviation 6.76
|
1.2 beats/min
Standard Deviation 13.86
|
PRIMARY outcome
Timeframe: Baseline; Day 14Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=54 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 14
|
0.4 beats/min
Standard Deviation 8.76
|
-1.4 beats/min
Standard Deviation 7.96
|
1.3 beats/min
Standard Deviation 10.49
|
PRIMARY outcome
Timeframe: Baseline; Day 30Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=53 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 30
|
0.1 beats/min
Standard Deviation 11.57
|
-0.9 beats/min
Standard Deviation 7.09
|
-0.5 beats/min
Standard Deviation 10.22
|
PRIMARY outcome
Timeframe: Baseline; Day 60Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=52 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 60
|
0.4 beats/min
Standard Deviation 11.14
|
0.3 beats/min
Standard Deviation 8.24
|
-2.1 beats/min
Standard Deviation 11.62
|
PRIMARY outcome
Timeframe: Baseline; Day 90Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=52 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 90
|
1.1 beats/min
Standard Deviation 10.58
|
-0.9 beats/min
Standard Deviation 8.76
|
0.0 beats/min
Standard Deviation 9.45
|
PRIMARY outcome
Timeframe: Baseline; Day 120Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=50 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=49 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 120
|
0.5 beats/min
Standard Deviation 12.39
|
-0.4 beats/min
Standard Deviation 9.24
|
0.8 beats/min
Standard Deviation 11.77
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Safety population included all participants who were administered study intervention.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Systolic and Diastolic Blood Pressure (BP) at Baseline
Systolic Blood Pressure
|
116.6 millimeters of mercury (mmHg)
Standard Deviation 12.62
|
119.7 millimeters of mercury (mmHg)
Standard Deviation 14.96
|
120.4 millimeters of mercury (mmHg)
Standard Deviation 13.38
|
|
Systolic and Diastolic Blood Pressure (BP) at Baseline
Diastolic Blood Pressure
|
77.2 millimeters of mercury (mmHg)
Standard Deviation 9.11
|
76.6 millimeters of mercury (mmHg)
Standard Deviation 9.26
|
77.6 millimeters of mercury (mmHg)
Standard Deviation 8.81
|
PRIMARY outcome
Timeframe: Baseline; Day 7Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=49 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=46 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 7
Systolic BP
|
1.2 mmHg
Standard Deviation 11.49
|
1.7 mmHg
Standard Deviation 13.37
|
-2.0 mmHg
Standard Deviation 11.14
|
|
Change From Baseline in Systolic and Diastolic BP at Day 7
Diastolic BP
|
-0.5 mmHg
Standard Deviation 6.66
|
0.3 mmHg
Standard Deviation 8.43
|
0.2 mmHg
Standard Deviation 8.57
|
PRIMARY outcome
Timeframe: Baseline; Day 14Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=54 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 14
Systolic BP
|
0.0 mmHg
Standard Deviation 9.29
|
1.9 mmHg
Standard Deviation 13.27
|
-1.7 mmHg
Standard Deviation 10.17
|
|
Change From Baseline in Systolic and Diastolic BP at Day 14
Diastolic BP
|
-1.0 mmHg
Standard Deviation 6.99
|
1.1 mmHg
Standard Deviation 8.69
|
-0.5 mmHg
Standard Deviation 7.41
|
PRIMARY outcome
Timeframe: Baseline; Day 30Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=53 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 30
Systolic BP
|
-2.0 mmHg
Standard Deviation 9.25
|
-0.7 mmHg
Standard Deviation 13.71
|
-2.8 mmHg
Standard Deviation 9.56
|
|
Change From Baseline in Systolic and Diastolic BP at Day 30
Diastolic BP
|
-1.3 mmHg
Standard Deviation 7.46
|
0.6 mmHg
Standard Deviation 8.77
|
-0.8 mmHg
Standard Deviation 9.01
|
PRIMARY outcome
Timeframe: Baseline; Day 60Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=52 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 60
Systolic BP
|
-1.2 mmHg
Standard Deviation 9.14
|
2.2 mmHg
Standard Deviation 14.49
|
-2.6 mmHg
Standard Deviation 15.00
|
|
Change From Baseline in Systolic and Diastolic BP at Day 60
Diastolic BP
|
-0.4 mmHg
Standard Deviation 6.50
|
1.9 mmHg
Standard Deviation 10.03
|
-2.4 mmHg
Standard Deviation 9.80
|
PRIMARY outcome
Timeframe: Baseline; Day 90Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=52 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 90
Systolic BP
|
1.4 mmHg
Standard Deviation 11.40
|
-0.3 mmHg
Standard Deviation 11.62
|
-2.7 mmHg
Standard Deviation 11.89
|
|
Change From Baseline in Systolic and Diastolic BP at Day 90
Diastolic BP
|
-2.4 mmHg
Standard Deviation 8.52
|
0.6 mmHg
Standard Deviation 7.14
|
-3.2 mmHg
Standard Deviation 10.18
|
PRIMARY outcome
Timeframe: Baseline; Day 120Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=50 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=49 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic and Diastolic BP at Day 120
Systolic BP
|
0.6 mmHg
Standard Deviation 12.05
|
0.1 mmHg
Standard Deviation 14.11
|
-1.3 mmHg
Standard Deviation 10.27
|
|
Change From Baseline in Systolic and Diastolic BP at Day 120
Diastolic BP
|
-0.7 mmHg
Standard Deviation 9.92
|
-0.4 mmHg
Standard Deviation 10.43
|
-0.5 mmHg
Standard Deviation 9.11
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Safety population included all participants who were administered study intervention.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Respiratory Rate at Baseline
|
15.6 breaths per minute (breaths/min)
Standard Deviation 2.53
|
15.5 breaths per minute (breaths/min)
Standard Deviation 2.66
|
15.6 breaths per minute (breaths/min)
Standard Deviation 2.51
|
PRIMARY outcome
Timeframe: Baseline; Day 7Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=49 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=46 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 7
|
-0.1 breaths/min
Standard Deviation 1.73
|
0.1 breaths/min
Standard Deviation 1.80
|
-0.2 breaths/min
Standard Deviation 1.65
|
PRIMARY outcome
Timeframe: Baseline; Day 14Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=54 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 14
|
-0.2 breaths/min
Standard Deviation 1.20
|
-0.1 breaths/min
Standard Deviation 2.05
|
0.0 breaths/min
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: Baseline; Day 30Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=53 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 30
|
-0.3 breaths/min
Standard Deviation 1.70
|
0.5 breaths/min
Standard Deviation 1.86
|
0.0 breaths/min
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: Baseline; Day 60Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=52 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 60
|
-0.2 breaths/min
Standard Deviation 1.83
|
-0.1 breaths/min
Standard Deviation 1.69
|
0.2 breaths/min
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: Baseline; Day 90Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=53 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=52 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 90
|
-0.3 breaths/min
Standard Deviation 1.85
|
-0.1 breaths/min
Standard Deviation 2.00
|
-0.2 breaths/min
Standard Deviation 2.04
|
PRIMARY outcome
Timeframe: Baseline; Day 120Population: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=50 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=49 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Day 120
|
-0.7 breaths/min
Standard Deviation 1.71
|
-0.2 breaths/min
Standard Deviation 2.09
|
-0.3 breaths/min
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: Day 14Population: mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses.
The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=54 Participants
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=51 Participants
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)
|
18.0 percentage of participants
Interval 7.4 to 28.6
|
75.9 percentage of participants
Interval 64.5 to 87.3
|
88.2 percentage of participants
Interval 79.4 to 97.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BOTOX® Low Dose
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
BOTOX® High Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 participants at risk
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 participants at risk
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/56 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
1.7%
1/59 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
0.00%
0/54 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/56 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
1.7%
1/59 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
0.00%
0/54 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® Low Dose
n=59 participants at risk
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
BOTOX® High Dose
n=54 participants at risk
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
|
|---|---|---|---|
|
General disorders
INJECTION SITE BRUISING
|
7.1%
4/56 • Number of events 4 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
6.8%
4/59 • Number of events 6 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
5.6%
3/54 • Number of events 3 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
5.4%
3/56 • Number of events 3 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
3.4%
2/59 • Number of events 2 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
1.9%
1/54 • Number of events 2 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.4%
3/56 • Number of events 3 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
0.00%
0/59 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
1.9%
1/54 • Number of events 1 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/56 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
0.00%
0/59 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
11.1%
6/54 • Number of events 10 • All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
|
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