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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 : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : April 7, 2020
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)
Actual Enrollment : 195 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
Actual Primary Completion Date : February 4, 2020
Estimated Study Completion Date : February 16, 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


Locations
Show Show 19 study locations
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    
Other Study ID Numbers: V25L-002
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes