Efficacy and safety of neuronox® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind, active-controlled study

• Published in: The Journal of dermatological treatment 2021-07, Vol.32 (5), p.561-567
• Main Authors: Lim, Youngkyoung, Lee, Jong Hee, Lee, Woo Shun, Lee, Weon Ju, Kim, Hei Sung, Shin, Min Kyung, Haw, Sik, Huh, Chang-Hun
• Format: Article
• Language: English
• Subjects: Adult; Botulinum toxin type A; Botulinum Toxins, Type A - administration & dosage; Double-Blind Method; efficacy; Female; Humans; lateral canthal lines; Male; Middle Aged; neuronox; onabotulinumtoxin a; safety; Skin Aging - drug effects; Treatment Outcome
• ISSN: 0954-6634; 1471-1753
• DOI: 10.1080/09546634.2019.1687818

Neuronox ® has not yet been investigated for its efficacy and safety in the treatment of lateral canthal lines (LCL). 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. 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. Treatment of moderate to severe LCL with Neuronox ® was effective and well-tolerated.