Volume Loss of the Jawline
Conditions
Brief 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
Detailed description
A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument. Treatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.
Interventions
DEVICERadiesse (+) Injectable Implant
Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator. 2. Is at least 18 years of age. 3. Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study. 4. Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
Exclusion criteria
1. 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. 2. Has had surgery on the jawbone or has surgical permanent implant to the face or neck. 3. Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease. 4. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events. 5. Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 | Week 4 | MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 4 | MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume, and; score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. The GAIS is a 7-point scale, where score ranges from (0-7) as: score 0: very much worse; score 1: much worse; score 3: worse; score 4: no change; score 5: improved; score 6: much improved; score 7: very much improved. An improvement on the GAIS for the treating investigator was classified as investigators who rated participants as improved, much improved, or very much improved. All other ratings on the GAIS were classified as no improvement. |
Participant flow
Recruitment details
The study was conducted at 2 sites in Canada.
Pre-assignment details
A total of 29 participants were screened for the study and all 29 participants were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group: Radiesse (+) Injectable Implant Participants received Radiesse+Lidocaine Injectable Implant up to 3.0cc volume, once within the jawline region of anterior to posterior boundaries (from the mentum to the earlobe) and superior to inferior boundaries (from the lower cheek to the lower body of the jawline). | 19 |
| Control Group: Untreated Participants did not receive jawline treatment. | 10 |
| Total | 29 |
Baseline characteristics
| Characteristic | Treatment Group: Radiesse (+) Injectable Implant | Control Group: Untreated | Total |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 7.01 | 59.2 years STANDARD_DEVIATION 6.39 | 57.3 years STANDARD_DEVIATION 6.83 |
| Fitzpatrick skin type Type I | 1 Participants | 2 Participants | 3 Participants |
| Fitzpatrick skin type Type II | 8 Participants | 4 Participants | 12 Participants |
| Fitzpatrick skin type Type III | 10 Participants | 2 Participants | 12 Participants |
| Fitzpatrick skin type Type IV | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin type Type V | 0 Participants | 2 Participants | 2 Participants |
| Fitzpatrick skin type Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 8 Participants | 27 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 10 |
| other Total, other adverse events | 19 / 19 | 0 / 10 |
| serious Total, serious adverse events | 0 / 19 | 0 / 10 |
Outcome results
Primary
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume.
Time frame: Week 4
Population: The full analysis set (FAS) comprised of the subset of participants in the randomized set for whom the primary efficacy variable was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group: Radiesse (+) Injectable Implant | Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 | Imputed data | 92.1 percentage of jawlines |
| Treatment Group: Radiesse (+) Injectable Implant | Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 | Observed data | 92.1 percentage of jawlines |
| Control Group: Untreated | Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 | Imputed data | 0 percentage of jawlines |
| Control Group: Untreated | Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4 | Observed data | 0 percentage of jawlines |
Comparison: Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.p-value: <0.000195% CI: [73.4, 98.8]Fisher Exact
Comparison: Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.p-value: <0.000195% CI: [73.4, 98.8]Fisher Exact
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
MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume, and; score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume. The GAIS is a 7-point scale, where score ranges from (0-7) as: score 0: very much worse; score 1: much worse; score 3: worse; score 4: no change; score 5: improved; score 6: much improved; score 7: very much improved. An improvement on the GAIS for the treating investigator was classified as investigators who rated participants as improved, much improved, or very much improved. All other ratings on the GAIS were classified as no improvement.
Time frame: Week 4
Population: The FAS comprised the subset of participants in the randomized set for whom the primary efficacy variable was available. The GAIS was assessed only in treated subjects (i.e., not in Control Group: Untreated); therefore, the analysis is on observed cases, where data were available for both assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group: Radiesse (+) Injectable Implant | 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 | GAIS improvement and MJAS ≥ 1-grade improvement | 92.1 percentage of jawlines |
| Treatment Group: Radiesse (+) Injectable Implant | 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 | iGAIS improvement and MJAS no improvement | 7.9 percentage of jawlines |
| Treatment Group: Radiesse (+) Injectable Implant | 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 | iGAIS no improvement and MJAS ≥ 1-grade improvement | 0 percentage of jawlines |
| Treatment Group: Radiesse (+) Injectable Implant | 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 | iGAIS no improvement and MJAS no improvement | 0 percentage of jawlines |