Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

November 10, 2023 updated by: Merz North America, Inc.
To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
      • Los Angeles, California, United States, 90069
        • Skin Care Center, Merz Investigational Site #0010099
      • Santa Monica, California, United States, 90404
        • Ava MD, Merz Investigational Site #0010299
      • Vista, California, United States, 92083
        • Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • AboutSkin Research LLC, Merz Investigational Site #0010103
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Skin Research Institute, Merz Investigational Site #0010101
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • MD Laser Skin & Vein Institute, Merz Investigational Site #0010323
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098
    • New York
      • New York, New York, United States, 10028
        • Skinfluence Medical PC, Merz Investigational #0010421
      • New York, New York, United States, 10065
        • Bass Plastic Surgery PLLC, Merz Investigational Site #0010419
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas, Merz Investigational Site #0010417
    • Texas
      • Austin, Texas, United States, 78746
        • Westlake Dermatology, Merz Investigational Site #0010322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
  2. Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
  3. Is greater than or equal to (>=) 22 and less than or equal to (<=) 65 years of age.

Exclusion Criteria:

  1. Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
  2. Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Radiesse (+)
Device: Radiesse (+)
Radiesse (+) for jawlines.
Other Names:
  • Radiesse (+) Injectable Dermal Filler with Lidocaine
Other: Control/Delayed Treatment with Radiesse (+)
Device: Radiesse (+)
Radiesse (+) for jawlines.
Other Names:
  • Radiesse (+) Injectable Dermal Filler with Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
Time Frame: At Week 12
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (>=) 1-point improvement.
At Week 12
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
Time Frame: Baseline up to end of study (Week 60)
Baseline up to end of study (Week 60)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Face-Q Satisfaction
Time Frame: Baseline up to Week 12
The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome).
Baseline up to Week 12
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
Time Frame: At Week 12
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
At Week 12
GAIS Scores as Assessed by Participants
Time Frame: At Week 12
GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
At Week 12
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
Time Frame: At Week 12
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a >=1-point improvement.
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Investigators

  • Study Director: Merz Medical Expert, Merz North America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

March 27, 2020

Study Completion (Actual)

March 27, 2020

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M900391004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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