A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of a new monophasic hyaluronic acid filler with lidocaine 0.3% in the correction of nasolabial fold

초록

BackgroundMany new brands of hyaluronic acid (HA) fillers are being introduced, but comparative research on the characteristics of similar products is limited. ObjectiveTo test the efficacy, tolerability, and safety of a HA filler with lidocaine, Dermalax implant plus (Across), which is used for correcting nasolabial folds (NLFs), and to compare the performance of that of Restylane Sub-Q((R)) (Q-Med). MethodsA total of 52 subjects with visible NLFs were enrolled in this randomized, multicenter, patient/evaluator-blind, active-controlled, matched-pair clinical study. Each subject was injected with Dermalax implant plus in one NLF and Restylane Sub-Q((R)) in the other. All participants were reassessed for cosmetic changes at 2, 8, 12, 16, and 24weeks. Wrinkle severity was rated using the 5-point Wrinkle Severity Rating Scale (WSRS). ResultsAt week 24, the mean improvement in the WSRS compared to baseline was 1.060.54 for the PLUS side and 0.69 +/- 0.58 for the Sub-Q side (week 2: 1.67 +/- 0.58 and 1.21 +/- 0.67, week 8: 1.60 +/- 0.63 and 1.23 +/- 0.65, week 12: 1.58 +/- 0.61 and 1.15 +/- 0.61, week 16: 1.02 +/- 0.54 and 0.60 +/- 0.53). Average values of pain evaluated by self-assessment 100-mm VAS score within 30minutes after the procedure in the PLUS and Sub-Q groups were 14.65 +/- 16.23 and 38.29 +/- 27.27, respectively. Both fillers were well tolerated, and adverse reactions were mild. ConclusionWe confirmed that the monophasic HA containing pre-incorporated lidocaine (PLUS) is not inferior to well-studied biphasic HA (Sub-Q) in correcting to severe nasolabial folds for 24weeks and less painful than biphasic HA not containing lidocaine.

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