Efficacy and Safety of Prabotulinumtoxin A and Onabotulinumtoxin A for Crow's Feet: A Phase 3, Multicenter, Randomized, Double-Blind, Split-Face Study.

ABSTRACT

BACKGROUND: Prabotulinumtoxin A has been shown to have efficacy for the treatment of upper-limb spasticity and improvement of moderate to severe glabellar lines. However, the efficacy and safety of prabotulinumtoxin A for crow's feet have not been evaluated. OBJECTIVE: This study compared the efficacy and safety of prabotulinumtoxin A and onabotulinumtoxin A in the treatment of crow's feet. PATIENTS AND METHODS: A multicenter, randomized, double-blind, active-controlled, split-face study was conducted in subjects with bilateral symmetric, moderate to severe crow's feet at maximum smile. The investigators assessed the severity of crow's feet by using the facial wrinkle scale, and the subjects reported the improvement in severity, their subjective satisfaction, and perceived age. The primary efficacy outcome was the proportion of subjects with Grade 0 or 1 severity of crow's feet at maximum smile at Week 4 as assessed by the investigators. RESULTS: In the primary efficacy outcome assessment, there was no significant difference between the 2 groups (prabotulinumtoxin A, 65.02%; onabotulinumtoxin A, 62.56%; p = .0956). All secondary efficacy outcomes were also achieved. Adverse events related to injection were mild and recovered spontaneously. CONCLUSION: Prabotulinumtoxin A and onabotulinumtoxin A have comparable efficacy and safety in the treatment of crow's feet.