N/A
Completed N=180
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Improvement of Jawline Contour
Source: ClinicalTrials.gov NCT03583359 ↗
Enrolled (actual)
180
Serious AEs
1.7%
Results posted
Jun 2022
Primary outcomePrimary: Responder Rate According to the Merz Jawline Assessment Scale (MJAS) — 75.6; 8.8 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate According to the Merz Jawline Assessment Scale (MJAS) |
75.6; 8.8 | <0.0001 sig |
| 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 |
36; 10; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Face-Q Satisfaction |
269.8; -9.4 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator |
37; 51; 27; 1; 0; 0 | — |
| SECONDARY GAIS Scores as Assessed by Participants |
32; 38; 39; 6; 1; 0 | — |
| SECONDARY Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) |
47.7; 8.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03583359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.