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Evaluation of the MJGS Following Radiesse (+) Injection Into the Jawline

NCT02904057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-12-10

Study results available
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Summary

This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument

Conditions

  • Volume Loss of the Jawline

Interventions

DEVICE

Radiesse (+) Injectable Implant

Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kuligowski, MD,PHD,MBA · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2016-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02904057 on ClinicalTrials.gov