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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03712137
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date February 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Official Title  ICMJE A Multicenter, Evaluator-blinded, Randomized, Parallelgroup, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Brief Summary This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Jawline Definition
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: VOLUX XC
  • 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.
    Intervention: Other: No-treatment control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2020)
195
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
256
Actual Study Completion Date  ICMJE January 26, 2021
Actual Primary Completion Date February 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03712137
Other Study ID Numbers  ICMJE V25L-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marta Sartor Allergan
PRS Account Allergan
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP