A Prospective, Randomized, Double-Blind, Split-Face, Comparative Study to Evaluate the Efficacy and Safety of DKL23 and Juvéderm Volift for Correcting Moderate-to-Severe Nasolabial Folds.

Abstract

Hyaluronic acid dermal fillers are used for multiple indications including wrinkle correction and restoration of volume/fullness. To compare the efficacy and safety of two hyaluronic acid products for correcting moderate to severe nasolabial folds. A prospective randomized double-blind split-face study. Subjects' left and right NLF were randomized for treatment with DKL23 and Juvéderm Volift. Follow-up was conducted at 1, 3, 6, and 9 months. The changes from baseline in wrinkle severity rating scale (WSRS) and Global Aesthetics Improvement Scale (GAIS) were evaluated. Post-treatment adverse events (AEs) were recorded. Forty-eight women (median age, 57.0 years) with skin type I-VI were enrolled. Both treatments showed statistically significant improvement (p<0.0001) in NLFs according to WSRS score from baseline to each of the timepoints assessed. The improvement in NLFs was maintained until the end of the study (9 months). Furthermore, the change from baseline to each of the timepoints assessed was similar between DKL23 and Juvéderm Volift. Investigator- and subject-rated GAIS showed similar rates of improvement (indicated by the sum of responses of improved, much or very much improved) between the 2 products. AEs reported in the study were in line with prior and expected experience after injection of hyaluronic acid dermal fillers. The types of AEs, their rates, intensity and duration were comparable between the 2 products. DKL23 improved NLF severity from baseline and up to 9 months with comparable improvement to that shown by Juvéderm Volift. Treatment was safe and well tolerated.