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

NCT03712137 | Completed Phase 3 Results FDA Device

• 1 other identifier: V25L-002
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Jawline Definition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

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

  Baseline to Month 6

Study Arms (2)

VOLUX XC

EXPERIMENTAL

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

No-treatment control

EXPERIMENTAL

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

Interventions

VOLUX XC DEVICE

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.

VOLUX XC

No-treatment control OTHER

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.

No-treatment control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (19)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

Artemedica

Santa Rosa, California, 95401, United States

Location

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, 20037, United States

Location

Susan H Weinkle, MD

Bradenton, Florida, 34209, United States

Location

Hevia Cosmetic Dermatology

Coral Gables, Florida, 33134, United States

Location

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

DeNova Research dba Arano, LLC

Chicago, Illinois, 60611, United States

Location

Callender Center for Clinical Research

Glenn Dale, Maryland, 20769, United States

Location

MDLSV

Hunt Valley, Maryland, 21030, United States

Location

Williams Center

Latham, New York, 12110, United States

Location

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Center aesthetic and dermatology

New York, New York, 10003, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Aesthetic Solutions, PA.

Chapel Hill, North Carolina, 27517, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Suzanne Bruce and Associates, P.A., The Center for Skin Research

Houston, Texas, 77056, United States

Location

SkinDC

Arlington, Virginia, 22209, United States

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Marta Sartor

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: November 12, 2018
• Primary Completion: February 4, 2020
• Study Completion: January 26, 2021
• Last Updated: January 4, 2023
• Results First Posted: January 4, 2023

Record last verified: 2022-09

Locations

US (19)