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RESEARCH PRODUCT

Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study

subject

description

Summary Background  Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects. Aim  To compare the efficacy and safety of a novel HA filler, HAE (Emervel Deep), with those of HAP (Restylane Perlane) in the treatment of severe nasolabial folds (NLF). Patients/Methods  A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HAE or HAP on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated. Results  At both weeks 12 and 24, the mean improvement in WSRS from baseline was significantly greater for HAE than for HAP (1.58 ± 0.89 vs. 1.33 ± 0.82 at week 24; P = 0.002). Similar volume of both products was injected at baseline and touch-up. Both fillers were well tolerated, with similar worst score distribution and mean score for erythema, edema/swelling, bruising, and pruritus. Significantly less severe pain/tenderness was reported with HAE than with HAP (P < 0.05). Conclusions  The new HA filler HAE provides better efficacy and similar local tolerability compared with HAP 6 months after the treatment of severe NLF.