Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition



Status:Recruiting
Healthy:No
Age Range:22 - Any
Updated:2/3/2019
Start Date:November 12, 2018
End Date:February 26, 2021
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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A Multicenter, Evaluator-blinded, Randomized, Parallelgroup, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel
for restoring jawline definition


Inclusion Criteria:

- Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using
the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the
same on both sides, but must be Grade 2 or 3

- Treating Investigator (TI) considers the subject's jaw amenable to an improvement of
at least 1 grade on the scale for the jawline definition

- Written Informed Consent (IC) has been obtained

Exclusion Criteria:

- Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone,
polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted
with any of these products during the study

- Has ever undergone fat injections in the malar, chin or jawline area or is planning to
undergo this procedure during the study

- Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite,
poly-L-lactic acid) below the subnasale within 36 months before enrollment or is
planning to undergo such treatment during the study

- Has received deoxycholic acid treatment in the submental region in the last 6 months

- Has active autoimmune disease

- Females who are pregnant, nursing, or planning a pregnancy during the course of the
study
We found this trial at
20
sites
Chapel Hill, North Carolina 27517
Phone: 310-858-1787
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Arlington, Virginia 22209
Phone: 703-966-7127
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Arlington, VA
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Bellaire, Texas 77401
Phone: 832-553-2339
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Bellaire, TX
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Birmingham, Alabama 35205
Phone: 205-933-0987
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Birmingham, AL
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Bradenton, Florida 34209
Phone: 941-794-5432
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Bradenton, FL
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Chicago, Illinois 60611
Phone: 919-403-6200
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Chicago, IL
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Coral Gables, Florida 33134
Phone: 305-443-9977
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Coral Gables, FL
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Coral Gables, Florida 33146
Phone: 305-443-6606
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Coral Gables, FL
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Glenn Dale, Maryland 20769
Phone: 202-955-5757
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Glenn Dale, MD
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Houston, Texas 77056
Phone: 713-985-0210
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Houston, TX
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Hunt Valley, Maryland 21030
Phone: 410-666-2839
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Hunt Valley, MD
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Latham, New York 12110
Phone: 518-786-7004
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Latham, NY
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11645 Wilshire Boulevard
Los Angeles, California 90025
Phone: 310-443-5273
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Los Angeles, CA
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Miami, Florida 33140
Phone: 305-531-5788
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Miami, FL
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Mount Kisco, New York 10549
Phone: 914-241-3003
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Mount Kisco, NY
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New York, New York 10003
Phone: 212-433-3344
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New York, NY
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New York, New York 10016
Phone: 312-335-2070
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New York, NY
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San Francisco, California 94115
Phone: 415-923-3377
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San Francisco, CA
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Santa Rosa, California 95401
Phone: 707-577-8292
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Santa Rosa, CA
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Washington, District of Columbia 20037
Phone: 202-955-5757
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Washington,
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