A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later.
Unnamed facility
Lyon, Auvergne-Rhône-Alpes, France
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side
The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).
Time frame: Baseline, Month 1
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).
Time frame: Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12
Injector Ease of Use on an 11-Point Scale
The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).
Time frame: Day 0
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.
Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.
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Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject's overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).
Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12