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

Merz Pharmaceuticals

Status

Completed

Conditions

Volume Loss of the Jawline

Treatments

Device: Radiesse (+) Injectable Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02904057

P140891

Details and patient eligibility

About

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

Full 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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.