Trial Outcomes & Findings for Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area (NCT NCT05167864)
NCT ID: NCT05167864
Last Updated: 2025-01-17
Results Overview
The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
day 3, day 30, day 90, day 180
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
OnabotulinumtoxinA
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
AbobotulinumtoxinA
Dysport
Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
IncobotulinumtoxinA
Xeomin
IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
PrabotulinumtoxinA
Jeuveau
PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
28
|
30
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
9
|
Reasons for withdrawal
| Measure |
OnabotulinumtoxinA
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
AbobotulinumtoxinA
Dysport
Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
IncobotulinumtoxinA
Xeomin
IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
PrabotulinumtoxinA
Jeuveau
PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
7
|
9
|
Baseline Characteristics
Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
Baseline characteristics by cohort
| Measure |
OnabotulinumtoxinA
n=35 Participants
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
AbobotulinumtoxinA
n=36 Participants
Dysport
Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
IncobotulinumtoxinA
n=36 Participants
Xeomin
IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
PrabotulinumtoxinA
n=36 Participants
Jeuveau
PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
43.5 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Declined to Answer
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: day 3, day 30, day 90, day 180Population: the change in dynamic strain is determined by measurements changes from two 3D images, if the images were not captured or the images were deemed unanalyzable then the population analyzed varies from the participant count.
The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.
Outcome measures
| Measure |
OnabotulinumtoxinA
n=34 Participants
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
AbobotulinumtoxinA
n=34 Participants
Dysport
Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
IncobotulinumtoxinA
n=34 Participants
Xeomin
IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
PrabotulinumtoxinA
n=36 Participants
Jeuveau
PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
|---|---|---|---|---|
|
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
Day 3
|
6.4 percent difference of neutral+dyanamic
Standard Deviation 5.0
|
10.9 percent difference of neutral+dyanamic
Standard Deviation 5.2
|
6.6 percent difference of neutral+dyanamic
Standard Deviation 5.6
|
8.9 percent difference of neutral+dyanamic
Standard Deviation 4.6
|
|
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
Day 30
|
8.6 percent difference of neutral+dyanamic
Standard Deviation 5.4
|
10.6 percent difference of neutral+dyanamic
Standard Deviation 6.2
|
9.2 percent difference of neutral+dyanamic
Standard Deviation 5.7
|
10.4 percent difference of neutral+dyanamic
Standard Deviation 4.3
|
|
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
Day 90
|
4.5 percent difference of neutral+dyanamic
Standard Deviation 4.6
|
5.7 percent difference of neutral+dyanamic
Standard Deviation 5.2
|
3.6 percent difference of neutral+dyanamic
Standard Deviation 5.3
|
5.2 percent difference of neutral+dyanamic
Standard Deviation 3.7
|
|
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
Day 180
|
0.18 percent difference of neutral+dyanamic
Standard Deviation 4.1
|
2.3 percent difference of neutral+dyanamic
Standard Deviation 5.6
|
2.6 percent difference of neutral+dyanamic
Standard Deviation 4.7
|
3.1 percent difference of neutral+dyanamic
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: baseline, day 3, day 30, day 90, day 180Population: population of who answered the FACE-Q can be analyzed
Correlation of patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime. Correlation is determined at each time point post intervention Day 3, Day 30, Day 90 and Day 180.
Outcome measures
| Measure |
OnabotulinumtoxinA
n=34 Participants
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
AbobotulinumtoxinA
n=34 Participants
Dysport
Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
|
IncobotulinumtoxinA
n=34 Participants
Xeomin
IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
PrabotulinumtoxinA
n=36 Participants
Jeuveau
PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
|
|---|---|---|---|---|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Satisfaction with Forehead Day 90
|
-0.028 correlation coefficient
Standard Error 0.087
|
-0.042 correlation coefficient
Standard Error 0.53
|
0.015 correlation coefficient
Standard Error 0.069
|
0.015 correlation coefficient
Standard Error 0.069
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Satisfaction with Forehead Day 180
|
-0.053 correlation coefficient
Standard Error 0.081
|
-0.010 correlation coefficient
Standard Error 0.044
|
-0.031 correlation coefficient
Standard Error 0.066
|
0.111 correlation coefficient
Standard Error 0.063
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines between Eyebrows Day 3
|
-0.015 correlation coefficient
Standard Error 0.031
|
0.046 correlation coefficient
Standard Error 0.047
|
0.064 correlation coefficient
Standard Error 0.043
|
-0.038 correlation coefficient
Standard Error 0.041
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines: Forehead Day 3
|
-0.0870 correlation coefficient
Standard Error 0.057
|
-0.013 correlation coefficient
Standard Error 0.052
|
0.049 correlation coefficient
Standard Error 0.661
|
-0.095 correlation coefficient
Standard Error 0.045
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines: Forehead Day 30
|
0.033 correlation coefficient
Standard Error 0.492
|
-0.018 correlation coefficient
Standard Error 0.061
|
-0.338 correlation coefficient
Standard Error 0.055
|
-0.0877 correlation coefficient
Standard Error 0.046
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines: Forehead Day 90
|
0.0327 correlation coefficient
Standard Error 0.053
|
-0.012 correlation coefficient
Standard Error 0.039
|
0.021 correlation coefficient
Standard Error 0.053
|
-0.039 correlation coefficient
Standard Error .045
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines: Forehead Day 180
|
-0.086 correlation coefficient
Standard Error 0.048
|
-0.065 correlation coefficient
Standard Error 0.064
|
-0.071 correlation coefficient
Standard Error 0.0501
|
-0.014 correlation coefficient
Standard Error 0.090
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Satisfaction with Forehead Day 3
|
-0.059 correlation coefficient
Standard Error 0.086
|
-0.010 correlation coefficient
Standard Error 0083
|
0.033 correlation coefficient
Standard Error 0.083
|
-0.059 correlation coefficient
Standard Error 0.051
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Satisfaction with Forehead Day 30
|
0.015 correlation coefficient
Standard Error 0.066
|
0.075 correlation coefficient
Standard Error 0.066
|
-0.002 correlation coefficient
Standard Error 0.070
|
-0.028 correlation coefficient
Standard Error 0.041
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines between Eyebrows Day 30
|
0.025 correlation coefficient
Standard Error 0.315
|
0.009 correlation coefficient
Standard Error 0.045
|
0.048 correlation coefficient
Standard Error 0.047
|
0.027 correlation coefficient
Standard Error 0.026
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines between Eyebrows Day 90
|
0.008 correlation coefficient
Standard Error 0.053
|
0.030 correlation coefficient
Standard Error 0.040
|
-0.015 correlation coefficient
Standard Error 0.046
|
0.009 correlation coefficient
Standard Error 0.028
|
|
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Appraisal of Lines between Eyebrows Day 180
|
0.024 correlation coefficient
Standard Error 0.041
|
0.015 correlation coefficient
Standard Error 0.069
|
-0.133 correlation coefficient
Standard Error 0.041
|
0.034 correlation coefficient
Standard Error 0.043
|
Adverse Events
OnabotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AbobotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IncobotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PrabotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place