The Second of Two One-Year, Multicenter,Open-Label, Repeat-Dose, Phase II SafetyStudies of PrabotulinumtoxinA for theTreatment of Moderate to Severe GlabellarLines in Adult Patients

Z. Paul Lorenc, MD, FACS; Jeffrey M. Adelglass, MD, FACS;

Rui L. Avelar, MD; Leslie Baumann, MD; Kenneth R. Beer, MD;

Joel L. Cohen, MD; Sue Ellen Cox, MD; Steven H. Dayan, MD;

Jeffrey S. Dover, MD; Jeanine B. Downie, MD; Zoe Diana Draelos, MD;

Mitchel P. Goldman, MD; John E. Gross, MD, FACS; John H. Joseph,

MD; Joely Kaufman-Janette, MD; Ronald L. Moy, MD; Mark Nestor, MD;

Joel Thomas Schlessinger, MD; Stacy R. Smith, MD; Robert A. Weiss, MD

Abstract

Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.

Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.

Methods: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study.

Results: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug–related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug–related AEs. Eight patients

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