Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
72
Single treatment, volume determined by investigator
Single treatment, volume determined by investigator
Unnamed facility
Mount Kisco, New York, United States
Procedural Pain Score
Evaluate pain 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 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Time frame: 1 day
Nasolabial Fold (NLF) Severity
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 Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.
Time frame: 2 weeks
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