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

Merz North America, Inc.180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Improvement of Jawline Contour

Interventions

Radiesse (+)DEVICE

Radiesse (+) for jawlines.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Responder Rate According to the Merz Jawline Assessment Scale (MJAS)

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.

Time frame: 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)

Secondary Outcomes

Percent Change From Baseline in Face-Q Satisfaction

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).

Time frame: Baseline up to Week 12

Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator

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

Time frame: At Week 12

GAIS Scores as Assessed by Participants

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

Time frame: At Week 12

Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)

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.

Time frame: At Week 12

Data from ClinicalTrials.gov

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