title: Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial.
abstract: BACKGROUND
  Various onabotulinumtoxinA doses are effective in treating forehead lines (FHL), with a trend toward lower doses.
  
  
  OBJECTIVE
  To evaluate efficacy and safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis area and glabellar complex are treated together.
  
  
  METHODS
  Adults with moderate-to-severe FHL received onabotulinumtoxinA 40 U (FHL, 20 U; glabellar lines [GL], 20 U), 30 U (FHL, 10 U; GL, 20 U), or placebo. Response was assessed at weeks 1, 2, day 30, and monthly to day 180. Coprimary efficacy end points were investigator- and subject-assessed Facial Wrinkle Scale scores of none or mild (day 30). Patient-reported outcomes, onset/duration of effect, and adverse events (AEs) were evaluated.
  
  
  RESULTS
  Responder rates (investigator/subject, respectively) were 40-U group, 91.2%/89.5%; 30-U group, 86.4%/81.4%; placebo, 1.7%/5.1%. OnabotulinumtoxinA resulted in significantly greater responder rates than placebo (p < .001). Adverse events were mild to moderate and similar between groups (most common AEs: nasopharyngitis [4.6%] and headache [4.0%]).
  
  
  CONCLUSIONS
  Treatment of FHL with onabotulinumtoxinA 40 and 30 U (in frontalis and glabellar complex muscles) was tolerable, effective, and sustained. Both doses significantly reduced FHL severity; however, the 40-U dose demonstrated a trend toward greater sustained benefit and longer duration of effect versus the 30-U dose, with similar AE rates.
authors: *Department of Dermatology, University of Toronto, Toronto, Ontario, Canada; †Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada, and Pacific Dermaesthetics, Vancouver, British Columbia, Canada; ‡Dermetics, Burlington, Ontario, Canada, and Department of Dermatology, McMaster University, Hamilton, Ontario, Canada; §Allergan plc, Irvine, California; ‖Allergan plc, Markham, Ontario, Canada.
authors: Nowell
authors: N
authors: Solish
authors: Jason K
authors: JK
authors: Rivers
authors: Shannon
authors: S
authors: Humphrey
authors: Channy
authors: C
authors: Muhn
authors: Chris
authors: C
authors: Somogyi
authors: Xiaofang
authors: X
authors: Lei
authors: Meetu
authors: M
authors: Bhogal
authors: Carrie
authors: C
authors: Caulkins
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005546:Forehead; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D017060:Patient Satisfaction; D058629:Plasma Skin Regeneration / Q000379:methods; D012649:Self Concept; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A