A Phase III Clinical Study of the Efficacy and Safety of Botulinum Toxin Type A (MASPORT) with DYSPORT for the Treatment of Glabellar Lines.

Abstract

Botulinum toxin type A is a widely used treatment of facial wrinkles. The objective of this study was to compare the efficacy and safety of a new botulinum toxin type A (Masport [abobotulinum toxin A], MasoonDarou Co) with DYSPORT® for the treatment of glabellar lines. 262 subjects with moderate-to-severe glabellar lines received either a fixed dose of 50 units of MASPORT® or DYSPORT® (Ipsen Company, England). Subjects were followed up at 14, 30, 60, 90 and 120 days after injection. Efficacy was assessed by investigator at maximum frown and rest and also by Subject Global Assessment of Change (SGA). The responders were defined as persons with +2 grade improvement from baseline for both investigator and patient assessment. The occurrence and duration of adverse effects were recorded up throughout the study. According to the investigator evaluations, the responder rate at maximum frown were 94.5% for MASPORT and 95.6% for DYSPORT group on day 30 and at rest were 85.45% and 85.68% for MASPORT and DYSPORT group, respectively. According to the subject self-assessment, the proportion of responders in MASPORT group at day 30 was 95.28% versus 97.04% for DYSPORT group. No serious drug related adverse effect was recorded in either study groups, and the rates of adverse effects were similar for both groups. Abobotulinum toxin A [MASPORT] is equally safe and effective as commercial product [DYSPORT] for the treatment of glabellar lines with the dose of 50 units, up to 120 days. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .