Coral Gables, Florida 33134


Purpose:

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


Criteria:

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


NCT ID:

NCT03712137


Primary Contact:

Study Director
Candice Harvey
Allergan

Clinical Trials Registry Team
Phone: 877-277-8566
Email: IR-CTRegistration@Allergan.com


Backup Contact:

N/A


Location Contact:

Coral Gables, Florida 33134
United States

Study Coordinator
Phone: 305-443-9977

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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