Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

Conditions
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Improvement of Jawline Contour

Intervention / Treatment
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* Device: Radiesse (+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS). Has the same MJAS score on both jawlines (that is, jawlines are symmetrical). Is greater than or equal to (>=) 22 and less than or equal to (<=) 65 years of age. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Radiesse (+)<br> | Device: Radiesse (+)<br>* Radiesse (+) for jawlines.<br>* Other names: Radiesse (+) Injectable Dermal Filler with Lidocaine;|
| Other: Control/Delayed Treatment with Radiesse (+)<br> | Device: Radiesse (+)<br>* Radiesse (+) for jawlines.<br>* Other names: Radiesse (+) Injectable Dermal Filler with Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Week 12 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline up to Week 12 | 
| Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). | At Week 12 | 
| GAIS Scores as Assessed by Participants | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). | At Week 12 | 
| 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. | At Week 12 |