To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications: 1. Marionette lines (treatment skin depressions) 2. Forehead contouring (face contouring)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Sterile gel in disposable syringe
Eurofins Pharmascan /ID# 243454
Lyon, France
Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image.
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Time frame: Baseline to 30 Days
Marionette Lines: Proportion of subjects with a ≥1-point change in the Marionette Line scale from baseline before treatment to 30 days post treatment.
The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines
Time frame: Baseline to 30 Days
Forehead Contouring: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their facial appearance. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Time frame: Baseline to 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a ≥1-point change in the Allergan Marionette Line scale from baseline before treatment to 3 months, 6 months, 9 months, 12 months
The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines
Time frame: Baseline before treatment to 3 months, 6 months, 9 months, 12 months
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Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor using a 3D image at 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Time frame: 3 months, 6 months, 9 months and 12 months
Marionette Lines: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their facial appearance. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Time frame: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Time frame: 30 days to 12 Months
Marionette Lines: Change in overall FACE-Q Appraisal of lines: marionette score from baseline to all administered timepoints
The participant assessed appraisal of marionette lines using the FACE-Q questionnaire measured on a 4-point scale where 1=Not At All, 2=A Little, 3=Moderately , 4=Extremely. The responses to the items on the questionnaire are converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Time frame: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects marionette lines
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months
Forehead Contouring: Volume change in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Volume change in the marionette lines using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Forehead Contouring: Contour changes in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects marionette lines
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months