Efficacy and safety of a new monophasic hyaluronic acid filler in the correction of nasolabial folds: a randomized, evaluator-blinded, split-face study.
Rhee DY, Won CH, Noh TK, Kim MS, Kim BJ, Park GH, An JS, Chang SE, Lee MW, Choi JH, Moon KC, Lim SH.
Source
Asan Medical Center, Dermatology, Seoul, Korea, Republic of.
Abstract
Abstract Background: Hyaluronic acid (HA) fillers such as Restylane? are frequently used for the correction of facial soft-tissue defects. Objective: To compare the efficacy and safety of Elravie?, a novel monophasic HA filler, and Restylane, a well-studied biphasic HA filler, in the treatment of moderate to severe nasolabial folds. Methods: In this randomized, evaluator-blinded, split-face comparative study, subjects were randomized for injections with Elravie? or Restylane? on their left or right side of the face. Efficacy was determined by calculating the change in the Wrinkle Severity Rating Score (WSRS) relative to baseline. Local safety was assessed on the basis of the subject diaries which recorded erythema, swelling, induration, pruritus, irritation, mass, hematoma, pain, and dryness. Results: At week 24, the mean improvement in WSRS from baseline was 2.18 ± 0.42 for the Elravie? side and 2.16 ± 0.41 for the Restylane? side. Both fillers were well tolerated and the adverse reactions were mild and transient in most cases. Conclusions: Elravie? provides non-inferior efficacy compared to Restylane? 6 months after being used to treat moderate to severe nasolabial folds.
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