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

Allergan206 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

206

Conditions

Jawline Definition

Interventions

VOLUX XCDEVICE

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 controlOTHER

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.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)

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)

Time frame: Month 6

Secondary Outcomes

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)

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.

Time frame: Month 6

Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)

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.

Time frame: Month 6

Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score

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)

Time frame: Baseline to Month 6

Data from ClinicalTrials.gov

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