An analysis of safety data from five phase III clinical trials on the use of botulinum neurotoxin type A-ABO for the treatment of glabellar lines

Aesthetic Surgery Journal
Mark RubinMark S Nestor

Abstract

A new formulation of a botulinum neurotoxin type A (BoNTA-ABO; Dysport [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ) was recently approved by the US Food and Drug Administration for the treatment of moderate to severe glabellar lines. This article summarizes the safety data from five phase III clinical trials investigating the use of BoNTA-ABO in the treatment of glabellar lines. Of the five phase III studies conducted, three were multicenter, randomized, placebo-controlled, double-blind studies and two were multicenter, open-label, repeat-dose studies (one of which was an extension trial). Two fixed-dose, placebo-controlled studies randomized a total of 416 patients to receive one 50-unit dose of BoNTA-ABO. The single variable-dose study randomized 544 patients to receive 50 to 80 units of BoNTA-ABO, as determined by gender and patient muscle mass. A substudy of this variable-dose study on QT/QTc prolongation included 50 patients randomized to BoNTA-ABO. One open-label repeat-dose study administered 50 units of BoNTA-ABO to 1200 patients. The single extension study (N = 1415) included both fixed (5423 treatments) and variable dosing (1337 treatments) following a protocol amendment. The extension study included pati...Continue Reading

Citations

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