NCT02904057

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Volume Loss of the Jawline

Interventions

Type	Name	Description
DEVICE	Radiesse (+) Injectable Implant	Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-09-16
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Regulatory

• FDA-regulated device study