Improvement of Jawline Contour
Conditions
Brief summary
To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.
Interventions
DEVICERadiesse (+)
Radiesse (+) for jawlines.
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS). 2. Has the same MJAS score on both jawlines (that is, jawlines are symmetrical). 3. Is greater than or equal to (\>=) 22 and less than or equal to (\<=) 65 years of age.
Exclusion criteria
1. Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study. 2. Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate According to the Merz Jawline Assessment Scale (MJAS) | At Week 12 | 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. |
| 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 | Baseline up to end of study (Week 60) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Face-Q Satisfaction | Baseline up to Week 12 | 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). |
| Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | At Week 12 | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). |
| GAIS Scores as Assessed by Participants | At Week 12 | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). |
| Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) | At Week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
15 investigational sites in the United States.
Pre-assignment details
A total of 180 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Radiesse (+) Right and left jawline injected with Radiesse (+). | 123 |
| Control/Delayed Treatment With Radiesse (+) Participants did not receive treatment for the first 12 weeks. | 57 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 12 | 3 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 6 |
Baseline characteristics
| Characteristic | Control/Delayed Treatment With Radiesse (+) | Total | Treatment With Radiesse (+) |
|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 6.6 | 55.3 years STANDARD_DEVIATION 7.1 | 55.5 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 31 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 149 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 145 Participants | 103 Participants |
| Sex: Female, Male Female | 44 Participants | 146 Participants | 102 Participants |
| Sex: Female, Male Male | 13 Participants | 34 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 53 |
| other Total, other adverse events | 25 / 122 | 7 / 53 |
| serious Total, serious adverse events | 1 / 122 | 2 / 53 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Radiesse (+) | 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 |
| Treatment With Radiesse (+) | 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 |
| Control/Delayed Treatment With Radiesse (+) | 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 | 10 Participants |
| Control/Delayed Treatment With Radiesse (+) | 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 |
Primary
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
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.
Time frame: At Week 12
Population: ITT population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse (+) | Responder Rate According to the Merz Jawline Assessment Scale (MJAS) | 75.6 percentage of participants |
| Control/Delayed Treatment With Radiesse (+) | Responder Rate According to the Merz Jawline Assessment Scale (MJAS) | 8.8 percentage of participants |
p-value: <0.000195% CI: [53.7, 75.2]Fisher's exact test
Secondary
GAIS Scores as Assessed by Participants
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Time frame: At Week 12
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Very Much Improved | 32 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Much Improved | 38 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Improved | 39 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | No Change | 6 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Worse | 1 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Much Worse | 0 Participants |
| Treatment With Radiesse (+) | GAIS Scores as Assessed by Participants | Very Much Worse | 0 Participants |
Secondary
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Time frame: At Week 12
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Very Much Improved | 37 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Much Improved | 51 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Improved | 27 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | No Change | 1 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Worse | 0 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Much Worse | 0 Participants |
| Treatment With Radiesse (+) | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | Very Much Worse | 0 Participants |
Secondary
Percent Change From Baseline in Face-Q Satisfaction
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).
Time frame: Baseline up to Week 12
Population: ITT population consisted of all randomized participants. Here overall number of participants analyzed were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Radiesse (+) | Percent Change From Baseline in Face-Q Satisfaction | 269.8 percent change |
| Control/Delayed Treatment With Radiesse (+) | Percent Change From Baseline in Face-Q Satisfaction | -9.4 percent change |
Secondary
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
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.
Time frame: At Week 12
Population: ITT population consisted of all randomized participants. Here overall number of participants analyzed were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse (+) | Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) | 47.7 percentage of participants |
| Control/Delayed Treatment With Radiesse (+) | Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) | 8.2 percentage of participants |