title: 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.
  
  
  METHODS
  Therapeutic, I.
authors.affiliation: Seoul, Republic of Korea From the Department of Dermatology, St. Paul Hospital, College of Medicine, Catholic University of Korea; and the Department of Dermatology, College of Medicine, Chung-Ang University.
authors.forename: Hong Jin
authors.initials: HJ
authors.lastname: Joo
authors.forename: Young Jun
authors.initials: YJ
authors.lastname: Woo
authors.forename: Jung Eun
authors.initials: JE
authors.lastname: Kim
authors.forename: Beom Joon
authors.initials: BJ
authors.lastname: Kim
authors.forename: Hoon
authors.initials: H
authors.lastname: Kang
mesh_terms: D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D000067548:Dermal Fillers / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004954:Esthetics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007271:Injections, Intradermal; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D015588:Observer Variation; D061214:Patient Safety; D018570:Risk Assessment; D015595:Skin Aging / Q000187:drug effects*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000067548:Dermal Fillers; D004338:Drug Combinations; D006820:Hyaluronic Acid; D008012:Lidocaine