Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline

Not Applicable

Completed

• Conditions: Volume Loss of the Jawline
• Interventions: Device: Radiesse (+) Injectable Implant

• Registration Number: NCT02904057
• Lead Sponsor: Merz North America, Inc.

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Status Verified: 2017-06
• Disposition First Submitted: 2017-06-07
• Disposition First Submitted QC: 2017-06-07
• Disposition First Posted: 2017-06-12
• Results First Submitted: 2020-10-20
• Results First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Results First Posted: 2020-12-10
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Radiesse (+) Injectable Implant	The treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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".