title: OnabotulinumtoxinA dose-ranging study for hyperdynamic perioral lines.
abstract: BACKGROUND
  Few dosing data on onabotulinumtoxinA to treat hyperdynamic perioral lines (POLs) are available. Studying onabotulinumtoxinA in controlled settings is beneficial to treating a hyperfunctional orbicularis oris.
  
  
  OBJECTIVE
  To compare the dose-response relationship of two doses of onabotulinumtoxinA in hyperdynamic POLs.
  
  
  METHODS
  Female subjects (N = 60) received injections of onabotulinumtoxinA at four sites totaling 7.5 U or 12.0 U. Subjects returned at weeks 2, 4, 8, 12, 16, and 20. POL severity and total lip satisfaction (TLS) were assessed at all visits.
  
  
  RESULTS
  Investigator-assessed POL severity was reduced through week 20 for 12.0 U (p < .01). POL reduction for 7.5 U persisted until week 16 (p < .05). Responder rates did not differ until week 12 (12.0 U, 77%; 7.5 U, 36%; p = .003). Subject-assessed TLS was improved (p < .05) at all time points for both groups except at week 20 (12.0 U; p = .06). Most adverse events (AEs) were mild to moderate in severity and typical for onabotulinumtoxinA treatment in the lips, and the incidence was dose-dependent.
  
  
  CONCLUSIONS
  OnabotulinumtoxinA provides significant reductions in POL severity and high levels of subject satisfaction. Lack of dose response and fewer AEs suggest that treatment of hyperdynamic POLs with 7.5 U appears adequate for up to 16 weeks.
authors.affiliation: AboutSkin Dermatology and DermSurgery, Englewood, CO 80113, USA. jcohenderm@yahoo.com
authors.forename: Joel L
authors.initials: JL
authors.lastname: Cohen
authors.forename: Steven H
authors.initials: SH
authors.lastname: Dayan
authors.forename: Sue Ellen
authors.initials: SE
authors.lastname: Cox
authors.forename: Ramana
authors.initials: R
authors.lastname: Yalamanchili
authors.forename: Greg
authors.initials: G
authors.lastname: Tardie
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008046:Lip; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D010781:Photography; D015595:Skin Aging / Q000187:drug effects*; D018709:Statistics, Nonparametric; D013997:Time Factors
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A