Clinical trial NCT03712137: Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Official title: A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Jawline Definition
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 206
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
timeFrame: Month 6
Secondary outcomes:
measure: 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)
timeFrame: Month 6
measure: Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 6
measure: Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score
timeFrame: Baseline to Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Santa Rosa
country: United States
facility: Artemedica
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery
state: District of Columbia
city: Bradenton
country: United States
facility: Susan H Weinkle, MD
state: Florida
city: Coral Gables
country: United States
facility: Hevia Cosmetic Dermatology
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Chicago
country: United States
facility: DeNova Research dba Arano, LLC
state: Illinois
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Hunt Valley
country: United States
facility: MDLSV
state: Maryland
city: Latham
country: United States
facility: Williams Center
state: New York
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic & Laser Surgery
state: New York
city: New York
country: United States
facility: Center aesthetic and dermatology
state: New York
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, PA.
state: North Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Arlington
country: United States
facility: SkinDC
state: Virginia
Study officials:
affiliation: Allergan
name: Marta Sartor
role: STUDY_DIRECTOR
References: