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Updated: Jan 4, 2026
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Published on: February 15, 2022
Efficacy and safety of neuronox® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind,
Youngkyoung Lim1, Jong Hee Lee1,2, Woo Shun Lee3
1Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Introduction:
Neuronox® has not yet been investigated for its efficacy and safety in the treatment of lateral canthal lines (LCL).
Methods:
This study was a randomized, double-blind, active drug controlled, multicenter, 16 week, Phase I/III study designed to determine the non-inferiority of Neuronox® compared to onabotulinumtoxin A (ONA) in the treatment of moderate to severe LCL. Thirty subjects in Phase I and 220 subjects in Phase III were randomized in a 1:1 ratio to receive a single treatment (24 U) of either Neuronox® or ONA. The primary endpoint of the Phase III study was the responder rate according to the proportion of subjects achieving Grade 0 (none) or 1 (mild) from 2 (moderate) or 3 (severe) in LCL severity at maximum smile as assessed by the investigators at Week 4. Additional efficacy endpoints and safety endpoints (adverse events) were also evaluated.
Results:
The primary endpoint was achieved as the proportion of responders was 83% for both Neuronox® and ONA, thus, supporting the non-inferiority of Neuronox® compare to ONA. The two groups also showed no statistical differences in safety analyses.
Conclusion:
Treatment of moderate to severe LCL with Neuronox® was effective and well-tolerated.
