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

NCT ID: NCT02904057

Last Updated: 2020-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Volume Loss of the Jawline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group

The treatment group will receive Radiesse (+) injectable implant up to 3.0 cc per jawline.

Group Type: EXPERIMENTAL

Radiesse (+) Injectable Implant

Intervention Type: DEVICE

Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.

Control Group

The control group is not treated. They will undergo assessments such as photographs, jaw grading and jaw function tests.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Radiesse (+) Injectable Implant

Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kuligowski, MD,PHD,MBA

Role: STUDY_DIRECTOR

Study Director

Other Identifiers

P140891

Identifier Type: -

Identifier Source: org_study_id