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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | The treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline. |
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| Control Group | No Intervention | The control group is not treated. They will undergo assessments such as photographs, jaw grading and jaw function tests. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse (+) Injectable Implant | Device | Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kuligowski, MD,PHD,MBA | Study Director | Study Director |
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A total of 29 participants were screened for the study and all 29 participants were enrolled and treated.
The study was conducted at 2 sites in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group: Radiesse (+) Injectable Implant | Participants received Radiesse+Lidocaine Injectable Implant up to 3.0 cubic centimeter (cc) 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). |
| FG001 | Control Group: Untreated | Participants did not receive jawline treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The randomized set comprised of participants enrolled and randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The full analysis set (FAS) comprised of the subset of participants in the randomized set for whom the primary efficacy variable was available. | Posted | Number | percentage of jawlines | Week 4 | Jawlines | Jawlines |
|
Baseline up to Week 4
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.de |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Week 4 |
| Control Group: Untreated |
Participants did not receive jawline treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Fitzpatrick skin type | Fitzpatrick skin type depends on the amount of melanin pigment in the skin. This is determined by constitutional colour (white, brown or black skin) and the result of exposure to ultraviolet radiation (tanning). It depends on type of skin where, skin type I:pale or white skin-always burns, does not tan;skin type II:fair skin-burns easily, tans poorly;skin type III:darker white skin-tans after initial burn;skin type IV:light brown skin-burns minimally, tans easily;skin type V:brown skin-rarely burns, tans darkly easily and skin type VI:dark brown or black skin-never burns, always tans darkly. | Count of Participants | Participants |
|
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).
| OG001 | Control Group: Untreated | Participants did not receive jawline treatment. |
|
|
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| 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". | 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. | Posted | Number | percentage of jawlines | Week 4 | Jawlines | Jawlines |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 19 |
| 19 |
| EG001 | Control Group: Untreated | Participants did not receive jawline treatment. | 0 | 10 | 0 | 10 | 0 | 10 |
| Injection site swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Nodule | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
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| iGAIS no improvement and MJAS no improvement |
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