Chestnut Hill, Massachusetts 02467

  • Improvement of Jawline Contour

Purpose:

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.


Criteria:

Inclusion Criteria: 1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the MJAS, as determined independently by the blinded evaluator and the treating investigator. 2. Has the same MJAS score on both jawlines (i.e., jawlines are symmetrical). 3. Is ≥22 and ≤65 years of age. 4. Has adequate understanding (reading, speaking and writing) of the local/regional language. Exclusion Criteria: 1. Skin or fat atrophy, other than age related, in the midfacial and/or jawline region or has been diagnosed with a connective tissue disorder. 2. Skin laxity and/or sun damage beyond typical for the subject's age. 3. Prior surgery on the jaw or in the jawline area (including temporomandibular joint replacement or anatomical surgical modification) or has a permanent implant or graft in the lower face and/or jawline area that could interfere with effectiveness assessments 4. Ever been treated with fat injections or permanent fillers (e.g., silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study. 5. Been treated with semi-permanent dermal fillers (e.g., 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. 6. Received lower face and/or jawline area treatments with porcine-based collagen fillers or with Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatments during participation in the study. 7. Undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to undergo oral surgery during participation in the study. 8. Subjects with any malocclusion(s) that are unstable and/or not reproducible or active/history of lockjaw. 9. Subjects with body mass index (BMI) of < 18.5 or ≥ 30. 10. Subjects who have gained or lost significant weight over the past 6 months (i.e. ≥ 2-unit change in BMI); or subjects who plan to gain or lose significant weight during study participation (i.e. ≥ 2-unit change in BMI). 11. Subjects with jawline contour that is masked and/or difficult to differentiate from the neck due to submental fat pad(s), significant neck lipodystrophy, and/or neck skin redundancy.


Study is Available At:


Original ID:

M900391004


NCT ID:

NCT03583359


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

22 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Merz North America, Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

180


Enrollment Type:

Actual


Overall Contact Information

Official Name:Merz Medical Expert
Study Director
Merz North America, Inc.

Study Dates

Start Date:August 8, 2018
Completion Date:March 27, 2020
Completion Type:Actual
Primary Completion Date:May 22, 2019
Primary Completion Type:Actual
Verification Date:May 2020
Last Changed Date:May 15, 2020
First Received Date:June 28, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Descriptive summary of the responder rates in the treatment group and the untreated control group at Week 12, according to the Merz Jawline Assessment Scale (MJAS).
Time Frame:Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the subject.
Time Frame:Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator.
Time Frame:Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Average percent change of the FACE-Q from baseline to Week 12
Time Frame:Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Descriptive summary of the FACE-Q satisfaction of the lower face and jawline for treated subjects at baseline and Week 12.
Time Frame:Week 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Comparison of the responder rate between the treatment group and the untreated control group at Week 12, according to the Merz Jawline Assessment Scale (MJAS)
Time Frame:Week 12
Safety Issues:False
Description:The MJAS is a 5-point scale.

Study Interventions

Intervention Type:Device
Name:Radiesse (+)
Description:Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl). Mode of application: intradermal and/or supraperiosteal injection in the jaw Region. Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline during the initial injection and at the optional Week 48 re-treatment, and 1.5cc per jawline during the optional touch-up.
Arm Name:Delayed Treatment with Radiesse (+)
Other Name:Radiesse® Injectable Dermal Filler with Lidocaine

Study Arms

Study Arm Type:Other
Arm Name:Delayed Treatment with Radiesse (+)
Description:Enrolled subjects will be randomized (2:1 allocation ratio) to either receive treatment with Radiesse (+) or delayed treatment with Radiesse (+).
Study Arm Type:Experimental
Arm Name:Treatment with Radiesse (+)
Description:Enrolled subjects will be randomized (2:1 allocation ratio) to either receive treatment with Radiesse (+) or delayed treatment with Radiesse (+).

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Merz North America, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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