New Orleans, Louisiana 70124

  • Improvement of Jawline Contour

Purpose:

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.


Criteria:

Inclusion Criteria: 1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the MJAS, as determined independently by the blinded evaluator and the treating investigator. 2. Has the same MJAS score on both jawlines (i.e., jawlines are symmetrical). 3. Is ≥22 and ≤65 years of age. 4. Has adequate understanding (reading, speaking and writing) of the local/regional language. Exclusion Criteria: 1. Skin or fat atrophy, other than age related, in the midfacial and/or jawline region or has been diagnosed with a connective tissue disorder. 2. Skin laxity and/or sun damage beyond typical for the subject's age. 3. Prior surgery on the jaw or in the jawline area (including temporomandibular joint replacement or anatomical surgical modification) or has a permanent implant or graft in the lower face and/or jawline area that could interfere with effectiveness assessments 4. Ever been treated with fat injections or permanent fillers (e.g., silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study. 5. Been treated with semi-permanent dermal fillers (e.g., 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. 6. Received lower face and/or jawline area treatments with porcine-based collagen fillers or with Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatments during participation in the study. 7. Undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to undergo oral surgery during participation in the study. 8. Subjects with any malocclusion(s) that are unstable and/or not reproducible or active/history of lockjaw. 9. Subjects with body mass index (BMI) of < 18.5 or ≥ 30. 10. Subjects who have gained or lost significant weight over the past 6 months (i.e. ≥ 2-unit change in BMI); or subjects who plan to gain or lose significant weight during study participation (i.e. ≥ 2-unit change in BMI). 11. Subjects with jawline contour that is masked and/or difficult to differentiate from the neck due to submental fat pad(s), significant neck lipodystrophy, and/or neck skin redundancy.


NCT ID:

NCT03583359


Primary Contact:

Study Director
Merz Medical Expert
Merz North America, Inc.


Backup Contact:

N/A


Location Contact:

New Orleans, Louisiana 70124
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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