Efficacy and Safety of a Novel Botulinum Toxin Type A Product for the Treatment of Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled Multicenter Study

Abstract

A new botulinum toxin type A (NBoNT) produced from the same strain of Clostridium botulinum as onabotulinumtoxinA (OBoNT) is widely used in Asia. To compare the efficacy and safety of NBoNT and OBoNT for moderate to severe glabellar wrinkles. A double-blind, randomized, active-controlled, phase III study was performed. Three hundred fourteen patients were randomized at a 1:1 ratio to receive 20U of toxin. The primary end point was the responder rate according to investigator live assessment at maximum frown at week 4. Secondary end points were responder rates according to investigator live assessment with frowning and at rest at weeks 8, 12, and 16, with additional photographic assessment by a panel of blinded raters 4weeks after injection. Subjective satisfaction scores were also evaluated. Four weeks after treatment, responder rates for maximum frown were 93.7% (133/142) in the NBoNT group and 94.5% (138/146) in the OBoNT group. For secondary end points, there was no significant difference between the two groups for any variable at any time point. Noninferiority of NBoNT was confirmed. There were no serious adverse effects with either toxin. NBoNT is equally as effective as OBoNT for the treatment of glabellar frown lines. Both toxins were well tolerated.