Completed

NCT Number: NCT03583359

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

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.

Completed

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Key information

Conditions

Improvement of Jawline Contour

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395, Beverly Hills, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.
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.

Treatment and study plan

Radiesse (+)

Device

Radiesse (+) for jawlines.

Other names: Radiesse (+) Injectable Dermal Filler with Lidocaine

Primary outcomes

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.
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)

Secondary outcomes

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).
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).
GAIS Scores as Assessed by Participants

Time frame: At Week 12

GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
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.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jul 11, 2018
Registry last updated: Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.