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

Phase 3

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
VOLUX XC	VOLUX XC	Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.
No-treatment control	No-treatment control	No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)	Month 6	The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	Month 6	The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)	Month 6	The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score	Baseline to Month 6	The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best)

Locations (19): Center aesthetic and dermatology
🇺🇸
New York, New York, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸
Birmingham, Alabama, United States
DeNova Research dba Arano, LLC
🇺🇸
Chicago, Illinois, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
🇺🇸
Houston, Texas, United States
Susan H Weinkle, MD
🇺🇸
Bradenton, Florida, United States
Baumann Cosmetic and Research Institute
🇺🇸
Miami, Florida, United States
Westside Aesthetics
🇺🇸
Los Angeles, California, United States
Center for Dermatology and Dermatologic Surgery
🇺🇸
Washington, District of Columbia, United States
Artemedica
🇺🇸
Santa Rosa, California, United States
Skin Research Institute LLC
🇺🇸
Coral Gables, Florida, United States
Hevia Cosmetic Dermatology
🇺🇸
Coral Gables, Florida, United States
MDLSV
🇺🇸
Hunt Valley, Maryland, United States
Bellaire Dermatology Associates
🇺🇸
Bellaire, Texas, United States
SkinDC
🇺🇸
Arlington, Virginia, United States
Callender Center for Clinical Research
🇺🇸
Glenn Dale, Maryland, United States
Williams Center
🇺🇸
Latham, New York, United States
The Center for Dermatology, Cosmetic & Laser Surgery
🇺🇸
Mount Kisco, New York, United States
Aesthetic Solutions, PA.
🇺🇸
Chapel Hill, North Carolina, United States
Laser & Skin Surgery Center of New York
🇺🇸
New York, New York, United States