Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
32
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Unnamed facility
Niagara Falls, Ontario, Canada
Procedural Pain Score
Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: 1 day
Comparative Pain
A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Time frame: 1 day
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity
Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Time frame: Day 0, Day 14
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity
Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Time frame: Day 0, Day 14
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