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Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition | Clinical Trials | Clareo Health

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

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

NCT03712137•Allergan

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (19)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Westside Aesthetics

Los Angeles, California, United States

Artemedica

Santa Rosa, California, United States

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, United States

Susan H Weinkle, MD

Bradenton, Florida, United States

Hevia Cosmetic Dermatology

Coral Gables, Florida, United States

Skin Research Institute LLC

Coral Gables, Florida, United States

Baumann Cosmetic and Research Institute

Miami, Florida, United States

DeNova Research dba Arano, LLC

Chicago, Illinois, United States

Callender Center for Clinical Research

Glenn Dale, Maryland, United States

Key Dates

Start Date

November 12, 2018

Primary Completion Date

February 4, 2020

Completion Date

January 26, 2021

Last Updated

January 4, 2023

Enrollment

206

ACTUAL participants

Conditions

Jawline Definition

Interventions

VOLUX XC

DEVICE

No-treatment control

OTHER

Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

NCT05622812

Jawline Definition

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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