Trial Outcomes & Findings for Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline (NCT NCT03583359)
NCT ID: NCT03583359
Last Updated: 2023-11-14
Results Overview
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\>=) 1-point improvement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
At Week 12
Results posted on
2023-11-14
Participant Flow
15 investigational sites in the United States.
A total of 180 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Treatment With Radiesse (+)
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
57
|
|
Overall Study
Treated Participants
|
122
|
53
|
|
Overall Study
COMPLETED
|
94
|
45
|
|
Overall Study
NOT COMPLETED
|
29
|
12
|
Reasons for withdrawal
| Measure |
Treatment With Radiesse (+)
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
6
|
|
Overall Study
Lost to Follow-up
|
12
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Baseline characteristics by cohort
| Measure |
Treatment With Radiesse (+)
n=123 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=57 Participants
Participants did not receive treatment for the first 12 weeks.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: ITT population consisted of all randomized participants.
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\>=) 1-point improvement.
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=123 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=57 Participants
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
|
75.6 percentage of participants
Interval 67.3 to 82.3
|
8.8 percentage of participants
Interval 3.8 to 18.9
|
PRIMARY outcome
Timeframe: Baseline up to end of study (Week 60)Population: The safety evaluation set (SES) was the subset of all participants who were exposed to study medication at least once.
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=122 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=53 Participants
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
Participants with Device and/or Injection Related TEAEs
|
36 Participants
|
10 Participants
|
|
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
Participants with Device and/or Injection Related Serious TEAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome).
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=115 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=53 Participants
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Face-Q Satisfaction
|
269.8 percent change
Interval 215.1 to 324.6
|
-9.4 percent change
Interval -28.2 to 9.5
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants in treatment with Radiesse (+) group.
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=116 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Very Much Improved
|
37 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Much Improved
|
51 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Improved
|
27 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
No Change
|
1 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Worse
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Much Worse
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Very Much Worse
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants in treatment with Radiesse (+) group.
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=116 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
GAIS Scores as Assessed by Participants
Very Much Improved
|
32 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Much Improved
|
38 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Improved
|
39 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
No Change
|
6 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Worse
|
1 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Much Worse
|
0 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Very Much Worse
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a \>=1-point improvement.
Outcome measures
| Measure |
Treatment With Radiesse (+)
n=111 Participants
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=49 Participants
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
|
47.7 percentage of participants
Interval 38.7 to 57.0
|
8.2 percentage of participants
Interval 3.2 to 19.2
|
Adverse Events
Treatment With Radiesse (+)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Control/Delayed Treatment With Radiesse (+)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment With Radiesse (+)
n=122 participants at risk
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=53 participants at risk
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
1.9%
1/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
|
Infections and infestations
Erysipelas
|
0.82%
1/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
0.00%
0/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
1.9%
1/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
Other adverse events
| Measure |
Treatment With Radiesse (+)
n=122 participants at risk
Right and left jawline injected with Radiesse (+).
|
Control/Delayed Treatment With Radiesse (+)
n=53 participants at risk
Participants did not receive treatment for the first 12 weeks.
|
|---|---|---|
|
General disorders
Injection site mass
|
10.7%
13/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
11.3%
6/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
|
General disorders
Injection site bruising
|
9.0%
11/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
1.9%
1/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
|
General disorders
Injection site pain
|
6.6%
8/122 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
7.5%
4/53 • From first treatment up to the end of study (Week 60)
The investigator reported AEs systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER