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

Not Applicable

Completed

• Conditions: Improvement of Jawline Contour
• Interventions: Device: Radiesse (+)

• Registration Number: NCT03583359
• Lead Sponsor: Merz North America, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Study Start: 2018-08-06
• Primary Completion: 2020-03-27
• Study Completion: 2020-03-27
• Disposition First Submitted: 2020-05-15
• Results First Submitted: 2022-05-10
• Results First Submitted QC: 2022-06-20
• Disposition First Submitted QC: 2022-06-20
• Results First Posted: 2022-06-28
• Disposition First Posted: 2022-06-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Radiesse (+)	Radiesse (+)	-
Control/Delayed Treatment with Radiesse (+)	Radiesse (+)	-

Primary Outcome Measures

Name	Time	Method
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)	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	Baseline up to end of study (Week 60)

Secondary Outcome Measures

Name	Time	Method
GAIS Scores as Assessed by Participants	At Week 12	GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).
Percent Change From Baseline in Face-Q Satisfaction	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).
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)	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.
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator	At Week 12	GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).

Trial Locations

Locations (15)

Skin Research Institute, Merz Investigational Site #0010101; 🇺🇸 Coral Gables, Florida, United States

Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358; 🇺🇸 Vista, California, United States

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

Skinfluence Medical PC, Merz Investigational #0010421; 🇺🇸 New York, New York, United States

Ava MD, Merz Investigational Site #0010299; 🇺🇸 Santa Monica, California, United States

Skin Care Center, Merz Investigational Site #0010099; 🇺🇸 Los Angeles, California, United States

Research Institute of the Southeast, LLC, Merz Investigational Site #0010420; 🇺🇸 West Palm Beach, Florida, United States

AboutSkin Research LLC, Merz Investigational Site #0010103; 🇺🇸 Greenwood Village, Colorado, 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

Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194; 🇺🇸 Charlotte, North Carolina, United States

Bass Plastic Surgery PLLC, Merz Investigational Site #0010419; 🇺🇸 New York, New York, United States

Clinical Research Center of the Carolinas, Merz Investigational Site #0010417; 🇺🇸 Charleston, South Carolina, United States

Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418; 🇺🇸 New Orleans, Louisiana, United States

Westlake Dermatology, Merz Investigational Site #0010322; 🇺🇸 Austin, Texas, United States