Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the Treatment of Glabellar Lines.

BACKGROUND

Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction.

OBJECTIVE

Comparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes.

MATERIALS AND METHODS

Phase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed.

RESULTS

At Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported.

CONCLUSION

Both ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.