Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

PrabotulinumtoxinA has been identified as an effective agent against crow’s feet. Our study, which included Korean patients with moderate to severe crow’s feet, was undertaken to compare the efficacy and safety of PrabotulinumtoxinA and placebo treatments. Of the 90 study participants, 60 received prabotulinumtoxinA (24 U), whereas 30 received a placebo. The primary outcome assessment included facial wrinkle grading by investigators. At week 4, 69.64% of patients in the prabotulinumtoxinA group exhibited minimal crow’s feet severity; in contrast, a 0% improvement was observed in the placebo group (p < 0.0001). At week 12, the improvement rates were 30.36% for prabotulinumtoxinA and 6.90% for the placebo, demonstrating a significant difference (p = 0.0152). Based on the independent review panel’s assessment at week 4, the improvement rate was 39.29% in the prabotulinumtoxinA group and 3.45% in the placebo group during maximum smiling. Additionally, patient satisfaction was notably higher in the prabotulinumtoxinA group (32.14%) than in the placebo group (10.34%) at week 4 (p = 0.0289). Both treatments displayed comparable safety profiles, with only mild local reactions reported as ADRs for one patient from the prabotulinumtoxinA group. Thus, prabotulinumtoxinA demonstrates significant potential as a potent and safe remedy for crow’s feet.