title: Safety and efficacy of RT002, an injectable botulinum toxin type A, for treating glabellar lines: results of a phase 1/2, open-label, sequential dose-escalation study.
abstract: BACKGROUND
  RT002 is a new injectable BoNTA product. This formulation limits the spread of BoNTA, potentially permitting safe administration of larger doses and possibly extending its duration of action.
  
  
  OBJECTIVE
  This phase 1/2 clinical study was designed to establish the safety of RT002 for the treatment of moderate-to-severe glabellar lines.
  
  
  METHODS
  Subjects were randomized into four groups (N=12/group). Cohorts 1-3 received escalating doses of RT002 ranging from half the equivalent dose of approved toxins up to twice the current dose levels. The safety of each dose was confirmed prior to administering the next dose. Subjects in Cohort 4 were treated with the highest dose and observed for 36 weeks or until GLSS returned to baseline.
  
  
  RESULTS
  All doses of RT002 were well-tolerated. Common AEs were headache and mild injection site reactions. At Week 4, all doses of RT002 were highly effective at maximum frown. Cohort 4 achieved 7 month median duration. At 6 months, 80% of subjects maintained a ≥1-point improvement in Investigator GLSS and 60% maintained WSS of None or Mild. Study limitations include an open-label design and modest number of subjects.
  
  
  CONCLUSIONS
  RT002 is a safe and effective BoNTA product with an extended duration of action.
authors.affiliation: *Private Clinic, Alvaro Obregon, Mexico, D.F.; †Private Clinic, Colonia Roma, Mexico, D.F.; ‡Revance Therapeutics, Inc., Newark, California.
authors.forename: Enrique
authors.initials: E
authors.lastname: Garcia-Murray
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Velasco Villasenor
authors.forename: Berenice
authors.initials: B
authors.lastname: Acevedo
authors.forename: Silvia
authors.initials: S
authors.lastname: Luna
authors.forename: Jane
authors.initials: J
authors.lastname: Lee
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Waugh
authors.forename: Carl S
authors.initials: CS
authors.lastname: Hornfeldt
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005546:Forehead; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects*; D010146:Pain / Q000139:chemically induced; D011537:Pruritus / Q000139:chemically induced; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C000595967:RT002 botulinum toxin