Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
NCT ID: NCT03712137
Last Updated: 2023-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2018-11-12
2021-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
22 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Marta Sartor
Role: STUDY_DIRECTOR
Allergan
Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Westside Aesthetics
Los Angeles, California, United States
Artemedica
Santa Rosa, California, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States
Susan H Weinkle, MD
Bradenton, Florida, United States
Hevia Cosmetic Dermatology
Coral Gables, Florida, United States
Skin Research Institute LLC
Coral Gables, Florida, United States
Baumann Cosmetic and Research Institute
Miami, Florida, United States
DeNova Research dba Arano, LLC
Chicago, Illinois, United States
Callender Center for Clinical Research
Glenn Dale, Maryland, United States
MDLSV
Hunt Valley, Maryland, United States
Williams Center
Latham, New York, United States
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States
Center aesthetic and dermatology
New York, New York, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Aesthetic Solutions, PA.
Chapel Hill, North Carolina, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Houston, Texas, United States
SkinDC
Arlington, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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V25L-002
Identifier Type: -
Identifier Source: org_study_id
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