A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds

Abstract

Background: Hyaluronic acid dermal fillers are most frequently used for unwanted wrinkles. Recently, lidocaine has been incorporated into hyaluronic acid fillers to reduce injection discomfort. Methods: A randomized, multicenter, double-blind, intraindividual trial was designed to compare a new lidocaine-containing monophasic hyaluronic acid filler (Neuramis Deep Lidocaine) with a lidocaine-containing biphasic hyaluronic acid filler (Restylane Perlane-L) in moderate to severe nasolabial folds. Fifty-eight patients with moderate to severe nasolabial folds were randomized to an injection of Neuramis or Perlane-L in the left or right side of the face. Clinical efficacy and safety were assessed by blinded investigators, independent expert panels, and patients based on the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale at weeks 8, 16, and 24 after the injection. Results: Wrinkle Severity Rating Scale improvement from baseline with Neuramis (1.64 +/- 0.74) was significantly greater than with Perlane-L (1.45 +/- 0.54) at week 24 (p < 0.05). The mean Global Aesthetic Improvement Scale score at week 24 was 2.36 +/- 0.55 for Neuramis and 2.00 +/- 0.50 for Perlane-L (p < 0.05). However, the difference in pain reduction between Neuramis- and Perlane-L-treated sides was not statistically significant. Conclusions: The efficacy and safety of Neuramis are comparable to those of Perlane-L in Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale improvement for the management of nasolabial folds. Furthermore, the difference in pain reduction between the two fillers was not clinically significant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.