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

NCT02904057 | Completed Results FDA Device

• 1 other identifier: P140891
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Conditions

Volume Loss of the Jawline

Outcome Measures

Primary Outcomes (1)

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

  MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume.

  Week 4

Secondary Outcomes (1)

• 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

  Week 4

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Device: Radiesse (+) Injectable Implant

Control Group

NO INTERVENTION

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

Interventions

Radiesse (+) Injectable Implant DEVICE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.de

+49 69 1503 1

Study Officials

• Michael Kuligowski, MD,PHD,MBA

  Study Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share