A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.
Unnamed facility
Cologne, Germany
Unnamed facility
Darmstadt, Germany
Unnamed facility
Naarden, Netherlands
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Month 12
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Day 0, Day 14, Month 1, Month 9
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Time frame: Day 14, Month 1, Month 9, Month 12
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
Time frame: Day 0, Day 14
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Day 0, Day 14, Month 1, Month 9, Month 12
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 14, Month 1, Month 9, Month 12
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).
Time frame: Day 0, Day 14, Month 12, Month 12.5