title: Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines: a randomized, double-blind, active-controlled multicenter study.
abstract: BACKGROUND
  A new botulinum toxin type A (NBoNT) produced from the same strain of Clostridium botulinum as onabotulinumtoxinA (OBoNT) is widely used in Asia.
  
  
  OBJECTIVE
  To compare the efficacy and safety of NBoNT and OBoNT for moderate to severe glabellar wrinkles.
  
  
  METHODS
  A double-blind, randomized, active-controlled, phase III study was performed. Three hundred fourteen patients were randomized at a 1:1 ratio to receive 20 U of toxin. The primary end point was the responder rate according to investigator live assessment at maximum frown at week 4. Secondary end points were responder rates according to investigator live assessment with frowning and at rest at weeks 8, 12, and 16, with additional photographic assessment by a panel of blinded raters 4 weeks after injection. Subjective satisfaction scores were also evaluated.
  
  
  RESULTS
  Four weeks after treatment, responder rates for maximum frown were 93.7% (133/142) in the NBoNT group and 94.5% (138/146) in the OBoNT group. For secondary end points, there was no significant difference between the two groups for any variable at any time point. Noninferiority of NBoNT was confirmed. There were no serious adverse effects with either toxin.
  
  
  CONCLUSIONS
  NBoNT is equally as effective as OBoNT for the treatment of glabellar frown lines. Both toxins were well tolerated.
authors.affiliation: Department of Dermatology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
authors.forename: Chong H
authors.initials: CH
authors.lastname: Won
authors.forename: Hyung M
authors.initials: HM
authors.lastname: Lee
authors.forename: Woo S
authors.initials: WS
authors.lastname: Lee
authors.forename: Hoon
authors.initials: H
authors.lastname: Kang
authors.forename: Beom J
authors.initials: BJ
authors.lastname: Kim
authors.forename: Won S
authors.initials: WS
authors.lastname: Kim
authors.forename: Ju H
authors.initials: JH
authors.lastname: Lee
authors.forename: Dong H
authors.initials: DH
authors.lastname: Lee
authors.forename: Chang H
authors.initials: CH
authors.lastname: Huh
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005138:Eyebrows; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D009498:Neurotoxins / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D010781:Photography; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors
chemical_list: D009498:Neurotoxins; D019274:Botulinum Toxins, Type A