title: A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of a new monophasic hyaluronic acid filler with lidocaine 0.3% in the correction of nasolabial fold.
abstract: BACKGROUND
  Many new brands of hyaluronic acid (HA) fillers are being introduced, but comparative research on the characteristics of similar products is limited.
  
  
  OBJECTIVE
  To test the efficacy, tolerability, and safety of a HA filler with lidocaine, Dermalax implant plus™ (Across), which is used for correcting nasolabial folds (NLFs), and to compare the performance of that of Restylane Sub-Q®(Q-Med).
  
  
  METHODS
  A total of 52 subjects with visible NLFs were enrolled in this randomized, multicenter, patient/evaluator-blind, active-controlled, matched-pair clinical study. Each subject was injected with Dermalax implant plus™ in one NLF and Restylane Sub-Q®in the other. All participants were reassessed for cosmetic changes at 2, 8, 12, 16, and 24 weeks. Wrinkle severity was rated using the 5-point Wrinkle Severity Rating Scale (WSRS).
  
  
  RESULTS
  At week 24, the mean improvement in the WSRS compared to baseline was 1.06±0.54 for the PLUS side and 0.69±0.58 for the Sub-Q side (week 2: 1.67±0.58 and 1.21±0.67, week 8: 1.60±0.63 and 1.23±0.65, week 12: 1.58±0.61 and 1.15±0.61, week 16: 1.02±0.54 and 0.60±0.53). Average values of pain evaluated by self-assessment 100-mm VAS score within 30 minutes after the procedure in the PLUS and Sub-Q groups were 14.65±16.23 and 38.29±27.27, respectively. Both fillers were well tolerated, and adverse reactions were mild.
  
  
  CONCLUSIONS
  We confirmed that the monophasic HA containing pre-incorporated lidocaine (PLUS) is not inferior to well-studied biphasic HA (Sub-Q) in correcting to severe nasolabial folds for 24 weeks and less painful than biphasic HA not containing lidocaine.
authors.affiliation: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Joon Hyuk
authors.initials: JH
authors.lastname: Suh
authors.affiliation: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Chang Taek
authors.initials: CT
authors.lastname: Oh
authors.affiliation: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Song I
authors.initials: SI
authors.lastname: Im
authors.affiliation: Department of Plastic and Reconstructive Surgery, Eulji General Hospital, School of Medicine, Eulji University, Seoul, Korea.
authors.forename: Jung Soo
authors.initials: JS
authors.lastname: Lim
authors.affiliation: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Beom Joon
authors.initials: BJ
authors.lastname: Kim
authors.affiliation: Department of Plastic and Reconstructive Surgery, Eulji General Hospital, School of Medicine, Eulji University, Seoul, Korea.
authors.forename: Jong Hun
authors.initials: JH
authors.lastname: Lee
mesh_terms: D000779:Anesthetics, Local / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D000067548:Dermal Fillers / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D012060:Rejuvenation; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D000779:Anesthetics, Local; D000067548:Dermal Fillers; D006820:Hyaluronic Acid; D008012:Lidocaine; C445361:Restylane
keywords: filler; hyaluronic acid; lidocaine; monophasic hyaluronic acid; nasolabial fold; pain