Randomized, placebo-controlled study of a new botulinum toxin type a for treatment of glabellar lines: Efficacy and safety

Fredric Brandt, Neil Swanson, Leslie Baumann, Barbara Huber

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Abstract

BACKGROUND A new botulinum toxin type A (BoNT-A) has been assessed in the United States for treatment of glabellar lines. In April 2009, the US FDA approved the Biologics License Application for a new US formulation of BoNT-A (Dysport [abobotulinumtoxinA]; Medicis Aesthetics Inc., Scottsdale, AZ). OBJECTIVE To compare efficacy and safety of a single treatment of BoNT-A with placebo in subjects with moderate to severe glabellar lines. METHODS AND MATERIALS One hundred fifty-eight subjects with moderate to severe glabellar lines were randomized 2:1 to receive 50 U of BoNT-A (n=105) or placebo (n=53). Responders were defined as having no or mild glabellar lines at 30 days posttreatment according to investigator and subject assessments (co-primary endpoint) using the validated Glabellar Line Scale Score at maximum frown. Subject diaries were used to document onset of effect. When conducting the research, the authors conformed to the ethical guidelines of the 1975 Declaration of Helsinki. RESULTS According to investigator assessment, the proportion of responders to BoNT-A at Day 30 was 89.5%, versus 7.5% for placebo (p

Original languageEnglish (US)
Pages (from-to)1893-1901
Number of pages9
JournalDermatologic Surgery
Volume35
Issue number12
DOIs
Publication statusPublished - Dec 2009

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ASJC Scopus subject areas

  • Dermatology
  • Surgery

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