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

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ClinicalTrials.gov Identifier: NCT03712137
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Jawline Definition Device: VOLUX XC Other: No-treatment control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Evaluator-blinded, Randomized, Parallelgroup, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 26, 2021

Arm Intervention/treatment
Experimental: VOLUX XC
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an 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 an 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) during 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) during the Post-Control period.




Primary Outcome Measures :
  1. Percentage of subjects who show ≥ 1-point jawline improvement from baseline on the Allergan Loss ofJawline Definition Scale (ALJDS) [ Time Frame: Change from Baseline to 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 :
  1. 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) [ Time Frame: Month 6 ]
    The Evaluating Investigator (EI) will assess the aesthetic improvement of the nose 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.

  2. Percentage of Participants who note "Improved" or "Much Improved" in jawline area as Assessed by the Participant using the GAIS [ Time Frame: Month 6 ]
    The participant will assess the aesthetic improvement of the nose 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.

  3. Change from baseline for FACE-Q™ Satisfaction with lower face and jawline score [ Time Frame: Change from baseline to Month 6 ]
    The subject will assess satisfaction using the 5 items on the Satisfaction of Lower Face and Jawline module of the FACE-Q™ questionnaire measured on a 4-point scale (1=Not at all, 2=A little, 3=Moderately, 4=Extremely), this will be converted to a single score from 0 to 100.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712137


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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United States, Alabama
Total Skin and Beauty Dermatology Center, PC Recruiting
Birmingham, Alabama, United States, 35205
Contact: Study Coordinator    205-933-0987      
United States, California
Westside Aesthetics Recruiting
Los Angeles, California, United States, 90025
Contact: Study Coordinator    310-443-5273      
Bay Area Laser Institute Withdrawn
San Francisco, California, United States, 94115
Artemedica Recruiting
Santa Rosa, California, United States, 95401
Contact: Study Coordinator    707-577-8292      
United States, District of Columbia
Center for Dermatology and Dermatologic Surgery Recruiting
Washington, District of Columbia, United States, 20037
Contact: Study Coordinator    202-955-5757      
United States, Florida
Susan H Weinkle, MD Recruiting
Bradenton, Florida, United States, 34209
Contact: Study Coordinator    941-794-5432      
Hevia Cosmetic Dermatology Recruiting
Coral Gables, Florida, United States, 33134
Contact: Study Coordinator    305-443-9977      
Skin Research Institute LLC Recruiting
Coral Gables, Florida, United States, 33146
Contact: Study Coordinator    305-443-6606 ext 125      
Baumann Cosmetic and Research Institute Recruiting
Miami, Florida, United States, 33137
Contact: Study Coordinator    305-531-5788      
United States, Illinois
DeNova Research dba Arano, LLC Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    919-403-6200      
United States, Maryland
Callender Center for Clinical Research Recruiting
Glenn Dale, Maryland, United States, 20769
Contact: Study Coordinator    202-955-5757      
MDLSV Recruiting
Hunt Valley, Maryland, United States, 21030
Contact: Study Coordinator    410-666-2839      
United States, New York
Williams Center Recruiting
Latham, New York, United States, 12110
Contact: Study Coordinator    518-786-7004      
The Center for Dermatology, Cosmetic & Laser Surgery Recruiting
Mount Kisco, New York, United States, 10549
Contact: Study Coordinator    914-241-3003      
Center aesthetic and dermatology Recruiting
New York, New York, United States, 10003
Contact: Study Coordinator    212-433-3344      
Laser & Skin Surgery Center of New York Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    312-335-2070      
United States, North Carolina
Aesthetic Solutions, PA. Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Study Coordinator    310-858-1787      
United States, Texas
Bellaire Dermatology Associates Recruiting
Bellaire, Texas, United States, 77401
Contact: Study Coordinator    832-553-2339      
Suzanne Bruce and Associates, P.A., The Center for Skin Research Recruiting
Houston, Texas, United States, 77056
Contact: Study Coordinator    713-985-0210 ext 112      
United States, Virginia
SkinDC Recruiting
Arlington, Virginia, United States, 22209
Contact: Study Coordinator    703-966-7127      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Candice Harvey Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03712137     History of Changes
Other Study ID Numbers: V25L-002
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents