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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

180

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2018

Geographic Reach

1 country

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

June 28, 2018

Completed

13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed

26 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

June 28, 2022

Completed

Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

June 28, 2018

Results QC Date

May 10, 2022

Last Update Submit

November 10, 2023

Conditions

Improvement of Jawline Contour

Outcome Measures

Primary Outcomes (2)

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.
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
Baseline up to end of study (Week 60)

Secondary Outcomes (4)

Percent Change From Baseline in Face-Q Satisfaction
Baseline up to Week 12
Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
At Week 12
GAIS Scores as Assessed by Participants
At Week 12
Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
At Week 12

Study Arms (2)

Treatment with Radiesse (+)

EXPERIMENTAL

Device: Radiesse (+)

Control/Delayed Treatment with Radiesse (+)

OTHER

Device: Radiesse (+)

Interventions

Radiesse (+)DEVICE

Radiesse (+) for jawlines.

Also known as: Radiesse (+) Injectable Dermal Filler with Lidocaine

Control/Delayed Treatment with Radiesse (+)Treatment with Radiesse (+)

Eligibility Criteria

Age22 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Merz North America, Inc.lead

Study Sites (15)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Beverly Hills, California, 90210, United States

Location

Skin Care Center, Merz Investigational Site #0010099

Los Angeles, California, 90069, United States

Location

Ava MD, Merz Investigational Site #0010299

Santa Monica, California, 90404, United States

Location

Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358

Vista, California, 92083, United States

Location

AboutSkin Research LLC, Merz Investigational Site #0010103

Greenwood Village, Colorado, 80111, United States

Location

Skin Research Institute, Merz Investigational Site #0010101

Coral Gables, Florida, 33146, United States

Location

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

West Palm Beach, Florida, 33401, United States

Location

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

New Orleans, Louisiana, 70124, United States

Location

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

Hunt Valley, Maryland, 21030, United States

Location

SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098

Chestnut Hill, Massachusetts, 02467, United States

Location

Skinfluence Medical PC, Merz Investigational #0010421

New York, New York, 10028, United States

Location

Bass Plastic Surgery PLLC, Merz Investigational Site #0010419

New York, New York, 10065, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194

Charlotte, North Carolina, 28207, United States

Location

Clinical Research Center of the Carolinas, Merz Investigational Site #0010417

Charleston, South Carolina, 29407, United States

Location

Westlake Dermatology, Merz Investigational Site #0010322

Austin, Texas, 78746, United States

Location

Related Publications (3)

Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442.
PMID: 34784131BACKGROUND
Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6.
PMID: 39505354DERIVED
Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27.
PMID: 38934231DERIVED

Results Point of Contact

Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH

Study Officials

Merz Medical Expert
Merz North America, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

August 6, 2018

Primary Completion

March 27, 2020

Study Completion

March 27, 2020

Last Updated

November 14, 2023

Results First Posted

June 28, 2022

Record last verified: 2023-11

Data Sharing

IPD Sharing: Will not share

Locations

US(15)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Treatment with Radiesse (+)

Control/Delayed Treatment with Radiesse (+)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Publications (3)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations