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

Completed · Phase 3

Conditions studied: Jawline Definition

In brief

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

Key facts

Study ID

NCT03712137

Run by

Allergan

People needed

206

Starts

2018-11-12

Expected to finish

2021-01-26

Last updated by the study team

2023-01-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• MDLSV — Hunt Valley, Maryland, United States
• Williams Center — Latham, New York, United States
• The Center for Dermatology, Cosmetic & Laser Surgery — Mount Kisco, New York, United States
• Center aesthetic and dermatology — New York, New York, United States
• Laser & Skin Surgery Center of New York — New York, New York, United States
• Aesthetic Solutions, PA. — Chapel Hill, North Carolina, United States
• Bellaire Dermatology Associates — Bellaire, Texas, United States
• Suzanne Bruce and Associates, P.A., The Center for Skin Research — Houston, Texas, United States
• SkinDC — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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