Clinical trial NCT02904057: Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline
Official title: Evaluation of the Merz Jawline Grading Scale (MJGS) Following Radiesse (+)® Correction of Subcutaneous Volume Loss and Contour Deficits of the Jawline - a Canadian Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Loss of the Jawline
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: 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
timeFrame: Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Study Director
name: Michael Kuligowski, MD,PHD,MBA
role: STUDY_DIRECTOR
References: