CompletedNot Applicable

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

29 participantsStarted 2016-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4

Timeframe: Week 4

Trial details

NCT IDNCT02904057

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2020-10-20

View on ClinicalTrials.gov More Volume Loss of the Jawline trials