title: Liquid Formulation of AbobotulinumtoxinA Exhibits a Favorable Efficacy and Safety Profile in Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trial.
abstract: BACKGROUND
  In most countries, approved botulinum toxin type A formulations require reconstitution before injection.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of a ready-to-use liquid formulation of abobotulinumtoxinA (abobotulinumtoxinA solution for injection, ASI) in subjects with moderate to severe glabellar lines (GL).
  
  
  METHODS
  In this Phase II, double-blind, placebo-controlled, randomized study, 176 female subjects (aged 30 to 60 years) were randomized into five treatment groups: ASI 20, 50, or 75 U, reconstituted abobotulinumtoxinA (aboBoNT-A) 50 U, and placebo. GL severity was assessed at maximum frown using a 4-point grading scale. Responders were subjects with severity grade of moderate [2] or severe [3] at baseline improving to none [0] or mild [1], evaluated at each time-point by Investigator's Live Assessment (ILA) or Subject's Self-Assessment (SSA). Safety profiles were also determined.
  
  
  RESULTS
  Baseline characteristics were similar across groups. Responder rates on Day 29 by ILA were significantly greater for ASI 20, 50, and 75 U versus placebo (88.9%, 91.4%, and 87.9% vs. 0%, respectively; P < 0.0001). Similar results were observed by SSA. A greater proportion of responders was observed in ASI groups vs placebo from Day 8 to 113 for ILA and SSA (P < 0.001). AboBoNT-A responder rate on Day 29 for ILA was 77.1% (P < 0.1006 vs ASI 50 U); with comparable results by SSA. The ASI safety profile was comparable to that of aboBoNT-A.
  
  
  CONCLUSIONS
  Ready-to-use liquid formulation of abobotulinumtoxinA was shown to be efficacious, with comparable results to reconstituted abobotulinumtoxinA, and to have a favorable safety profile in subjects with severe to moderate GL.
authors.affiliation: Plastic and Reconstructive Surgeon at the Iena Plastic Surgery Clinic, Paris, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Ascher
authors.affiliation: Plastic Surgeon at the Mediti Centre, Antibes-Juan Les Pins, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Kestemont
authors.affiliation: Dermatologist at the Dermatology Clinic, Bordeaux, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Boineau
authors.affiliation: Dermatologist at the Dermatology Department, Cannes Hospital, Cannes, France.
authors.forename: Isaac
authors.initials: I
authors.lastname: Bodokh
authors.affiliation: Senior Specialist at the Dresden Center of Outpatient Dermatosurgery, University Hospital Dresden, Dresden, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Stein
authors.affiliation: Dermatologists at the Starnberg Skin Centre, Starnberg, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Heckmann
authors.affiliation: Dermatologists at the Starnberg Skin Centre, Starnberg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Dendorfer
authors.affiliation: Dermatologist at the Private Practice for Dermatology and Aesthetics Dr Pavicic, Munich, Germany.
authors.forename: Tatjana
authors.initials: T
authors.lastname: Pavicic
authors.affiliation: Statistician at Ipsen Innovation, Les Ulis, Paris, France.
authors.forename: Magali
authors.initials: M
authors.lastname: Volteau
authors.affiliation: Medical Development Director for Ipsen Innovation at the time of this trial.
authors.forename: Anissa
authors.initials: A
authors.lastname: Tse
authors.affiliation: VP for Neurology Development at Ipsen Innovation, Les Ulis, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Picaut
authors.affiliation: Dermatologist and Clinical Epidemiologist (ScM) at RZANY & HUND, a private practice in Berlin, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Rzany
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; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage / Q000009:adverse effects; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D065087:Acetylcholine Release Inhibitors; D010919:Placebos; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA