A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.
Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.
Total Skin and Beauty Dermatology Center P.C.
Birmingham, Alabama, United States
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.
Time frame: Baseline, Month 6
Percentage of Nasolabial Folds With ≥1-Point Improvement
Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.
Time frame: Baseline, Month 6
Percentage of Nasolabial Folds With ≥1-Point Improvement
Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.
Time frame: Baseline, Month 12
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Skin Research Institute
Coral Gables, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Time frame: Baseline, Month 12