Evaluation of Variable-Dose Treatment with a New U.S. Botulinum Toxin Type A (Dysport) for Correction of Moderate to Severe Glabellar Lines: Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

Abstract

A single treatment with Dysport, with the dose based on gender and muscle mass, is well tolerated and provides a greater and longer-lasting improvement in glabellar lines compared with placebo.

A Review of AbobotulinumtoxinA (Dysport)

“…Using the composite 2+ grade improvement assessment for the response to the 50-U dose at maximum frown at day 30, 57% of patients (111/196; P < .001) achieved a 2+ grade improvement versus 0% for placebo. 9 The variable-dose study by Kane et al 4 achieved similar results of 59% (319/538), compared with less than 1% for placebo, suggesting that variable dosages selected appropriately based on muscle mass and other relevant factors yield desirable outcomes. A higher number of patients achieved a successful outcome using the 1+ grade improvement, with 76.5% of patients (150/196) receiving 50 U noting improvement at 30 days versus 1% in the placebo group.…”

“…In particular, the 4-point Glabellar Line Severity Scale (GLSS) was widely used at predefined follow-up assessments by investigators, blinded evaluators, and/or patients (Table 1). Here, we discuss the combined results of 2 fixed-dosage trials by Brandt et al 7 and Rubin et al, 8 as well as the aforementioned variable-dosage study by Kane et al, 4 and the fixed-dosage open-label extension study by Moy et al 5 The primary end point for efficacy among all 4 studies was a composite 2+ grade improvement on the GLSS from baseline at day 30, per request from the US Food and Drug Administration. A secondary end point was a composite 1+ grade improvement.…”

“…2,3 However, given that doses of BoNTA are generally customized based on the size and strength of the glabellar complex muscles, a phase 3 study by Kane et al 4 was conducted with a range of doses to determine their effects on safety and efficacy. In this later study, 816 patients were randomized to receive abobotulinumtoxinA or placebo in the double-blind study.…”

“…A higher number of patients achieved a successful outcome using the 1+ grade improvement, with 76.5% of patients (150/196) receiving 50 U noting improvement at 30 days versus 1% in the placebo group. 4 Several studies [6][7][8] demonstrate that approximately 50% of patients continue to have a response at maximal frown 90 days after injection. That response rate was increased when the dose was selected based on the patient's muscle mass.…”

Complications of Botulinum Toxin-A Injection in an Iranian Population

“…The unpleasant outcomes and complications are ultimately self-limiting. These self-limiting reactions include a headache, bruising, swelling, mild pain in the injection site and Flu-like symptoms that occur in about 3% of the patients who are exposed to repeated injections (7)(8)(9).…”