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Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline | Clinical Trials | Clareo Health

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

NCT03583359•Merz North America, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (15)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Beverly Hills, California, United States

Skin Care Center, Merz Investigational Site #0010099

Los Angeles, California, United States

Ava MD, Merz Investigational Site #0010299

Santa Monica, California, United States

Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358

Vista, California, United States

AboutSkin Research LLC, Merz Investigational Site #0010103

Greenwood Village, Colorado, United States

Skin Research Institute, Merz Investigational Site #0010101

Coral Gables, Florida, United States

Research Institute of the Southeast, LLC, Merz Investigational Site #0010420

West Palm Beach, Florida, United States

Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418

New Orleans, Louisiana, United States

MD Laser Skin & Vein Institute, Merz Investigational Site #0010323

Hunt Valley, Maryland, United States

SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098

Chestnut Hill, Massachusetts, United States

Key Dates

Start Date

August 6, 2018

Primary Completion Date

March 27, 2020

Completion Date

March 27, 2020

Last Updated

November 14, 2023

Enrollment

180

ACTUAL participants

Conditions

Improvement of Jawline Contour

Interventions

Radiesse (+)

DEVICE