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

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

Study Overview

• Status: Completed
• Conditions: Jawline Definition
• Intervention / Treatment: Device: VOLUX XC; Other: No-treatment control

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • California
    • Los Angeles, California, United States, 90025
      • Westside Aesthetics
    • Santa Rosa, California, United States, 95401
      • ArteMedica
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Center for Dermatology and Dermatologic Surgery
  • Florida
    • Bradenton, Florida, United States, 34209
      • Susan H Weinkle, MD
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute LLC
    • Coral Gables, Florida, United States, 33134
      • Hevia Cosmetic Dermatology
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research dba Arano, LLC
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center for Clinical Research
    • Hunt Valley, Maryland, United States, 21030
      • MDLSV
  • New York
    • Latham, New York, United States, 12110
      • Williams Center
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetic & Laser Surgery
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York
    • New York, New York, United States, 10003
      • Center aesthetic and dermatology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Aesthetic Solutions, PA.
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, P.A., The Center for Skin Research
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	Baseline to Month 6

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Marta Sartor, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: V25L-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes