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

BACKGROUND: The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines. OBJECTIVE: To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose.

BACKGROUND: Botulinum toxin is used to treat glabellar lines, but the optimal dose of Reloxin (Dysport, Ipsen Biopharm Ltd.) for this indication remains to be established. OBJECTIVE: The objective was to evaluate three doses of Reloxin to determine its efficacy and safety in treating glabellar lines. METHODS AND MATERIALS: Participants were given 20, 50, or 75 U of Reloxin, or placebo, injected across the glabella. Follow-up was on Days 7, 30, 60, 90, and 120. Adverse events were also elicited by telephone on Day 3. RESULTS: From investigators' and participants' assessments at Day 30, there were significantly more responders in each Reloxin-treated group than placebo (p< or = 0.001). The 50-U dose was as effective as the 75-U dose, with a similar duration. The most common adverse events were mild headache and nasopharyngitis, occurring similarly in all groups. CONCLUSIONS: Reloxin (Dysport/botulinum toxin type A) treatment resulted in a significant improvement in glabellar lines, and the 50-U dose was identified as optimal. All doses were well tolerated.