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.

BACKGROUND: Many new brands of hyaluronic acid (HA) fillers are being introduced, but comparative research on the characteristics of similar products is limited.

OBJECTIVE: To 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® (Q-Med).

METHODS: A 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® in the other. All participants were reassessed for cosmetic changes at 2, 8, 12, 16, and 24 weeks. Wrinkle severity was rated using the 5-point Wrinkle Severity Rating Scale (WSRS).

RESULTS: At week 24, the mean improvement in the WSRS compared to baseline was 1.06±0.54 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 30 minutes 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.

CONCLUSION: We 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 24 weeks and less painful than biphasic HA not containing lidocaine.