Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment for Moderate to Severe Glabellar Lines.

Abstract

The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines. To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines. A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed. Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≥1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment. Most ABO-treated subjects sustained ≥1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated.