Comparison of Hyaluronic Acid Gel With (HARDL) and Without Lidocaine (HAJUP) in the Treatment of Moderate-To-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded Study

BACKGROUND Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly used to smooth age-related facial creases and wrinkles. OBJECTIVE To compare efficacy and safety of a HA gel with lidocaine formulated by XpresHAn Technology (HA RDL ) with a HA gel without lidocaine produced by Hylacross technology (HA JUP ) in the treatment of moderate-to-severe nasolabial folds. MATERIALS AND METHODS Subjects ( n = 162) received initial and touch-up injections with HA RDL and HA JUP on either side of the face. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS Mean (SD) Wrinkle Severity Rating Scale was improved by 1.1 (0.75) and 1.1 (0.68) with HA RDL and HA JUP , respectively, at 24 weeks; improvements were sustained up to Week 48 with both treatments. Noninferiority of HA RDL was demonstrated (mean difference −0.09 [95% confidence interval: −0.18 to −0.01], p = .032) at 24 weeks. Adverse events were reported in 43% subjects, 12% were treatment related, with a similar distribution for both treatments. CONCLUSION Effectiveness and safety profiles of HA RDL and HA JUP were comparable.