Effectiveness and Safety of STYLAGE L Lidocaine in the Treatment of Nasolabial Folds (NICE Study): A Randomized, Double-Blind, Split-Face Controlled Study.

[BACKGROUND] Prominent nasolabial folds (NLFs) are a typical manifestation of aging. Hyaluronic acid (HA)-based injectable fillers are commonly used for correction. The NICE Study primarily evaluated non-inferiority of STYLAGE L Lidocaine (STYL-L), a cross-linked HA filler with lidocaine, versus the similar product Juvéderm ULTRA 3 (JUV-3) in correcting moderate to severe NLFs.

[METHODS] This was a double-blind, randomized, controlled, within-subject (split-face) study with 12 months follow-up. The primary endpoint was mean change in Wrinkle Severity Rating Scale (WSRS) score from baseline to 6 months after treatment initiation. Secondary endpoints included differences in NLF depth using interference fringe projection profilometry, Global Aesthetic Improvement Scale (GAIS), subject satisfaction, pain during injection, and tolerance.

[RESULTS] Of the 50 subjects randomized, 47 were analyzed. In the primary endpoint analysis, non-inferiority of STYL-L to JUV-3 was demonstrated as the upper limit of the 95% confidence interval (CI) was inferior to 0.5 (difference [95% CI] in WSRS change from baseline at 6 months was 0.11 [-0.07; 0.28]). NLF average depth was similarly reduced with STYL-L and JUV-3 at 1 month (adjusted mean [standard error] decrease of 0.049 [0.003] mm and 0.049 [0.004] mm, respectively), and generally maintained. Both evaluators and subjects considered NLFs improved, with all or almost all subjects classed as GAIS responders with both devices throughout the study. Overall subject satisfaction was high. Pain ratings were low. Both devices were well tolerated.

[CONCLUSIONS] Non-inferiority of STYL-L versus JUV-3 in improving NLFs was demonstrated. Results up to 12 months suggest comparable effectiveness and safety profiles.

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