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

Merz Pharmaceuticals

Status: Completed

Conditions: Improvement of Jawline Contour

Treatments: Device: Radiesse (+)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583359

M900391004

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Treatment with Radiesse (+)

Experimental group

Treatment:

Device: Radiesse (+)

Control/Delayed Treatment with Radiesse (+)

Other group

Treatment:

Device: Radiesse (+)