N/A
Completed N=29
Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline
Volume Loss of the Jawline
Source: ClinicalTrials.gov NCT02904057 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 — 92.1; 0; 92.1; 0 percentage of jawlines — p=<0.0001
Summary
This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 |
92.1; 0; 92.1; 0 | <0.0001 sig |
| SECONDARY Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4 |
92.1; 7.9; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
- Is at least 18 years of age.
- Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
Exclusion Criteria
- Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
- Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
- Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
- Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
- Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
Data sourced from ClinicalTrials.gov (NCT02904057). 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.