Randomized, double‐blind, active‐controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet

Abstract

Background Letibotulinum toxin A (LeBA) was approved by the Ministry of Food and Drug Safety (known as the Korea Food & Drug Administration) for cosmetic indications in 2012. However, the efficacy and safety of this newly introduced LeBA have not been investigated in crow's feet lines (CFL) treatment and standardization before its universal use. Objective The aim of this multicentre, double‐blind, randomized, parallel, active‐controlled Phase III clinical trial with two stages (http://ClinicalTrials.gov identifier: NCT03408236) was to investigate the non‐inferiority of LeBA vs. the existing onabotulinum toxin A (OnBA) for the treatment of CFL. Methods A total of 240 subjects were randomized to either the test (LeBA) or control (OnBA) group. At the baseline and at weeks 4 while maximum smiling (primary efficacy assessment), 8, 12 and 16, investigator's on‐site evaluation, independent evaluator, evaluation by the subjects, subjects' satisfaction assessment and safety assessment were performed. Results At week 4, the response rate of primary efficacy assessment was 69.75% and 68.33% in the test (LeBA) and control (OnBA) groups, respectively, without a significant difference. Other minor secondary evaluation results showed significant differences suggesting that LeBA offered better improvement than OnBA, but the overall results did not show significant differences between the two groups. Conclusion This study showed that LeBA was as effective and safe as OnBA for the treatment of CFL at the same doses.

Botulax and the US development

“…There was no significant difference in total adverse events between those treated with LeBA versus onabotulinumtoxinA. 2 When LeBA was compared to onabotulinumtoxinA in the treatment of dynamic foot deformity in children with cerebral palsy, there were no significant differences in adverse events between the two groups. 4 The incidence of adverse events, drug reactions, and serious events was not significantly different when LeBA was compared to onabotulinumtoxinA for the treatment of poststroke upper limb spasticity.…”

“…69.5% of people treated with LeBA had improvements and 68.33% of people treated with onabotulinumtoxinA had improvement. This suggests that LeBA is as effective as onabotulinumtoxinA at the same doses 2 …”

“…This suggests that LeBA is as effective as onabotulinumtoxinA at the same doses. 2 LeBA was also evaluated for use in the treatment of dynamic foot deformity in children with cerebral palsy. It was determined that LeBA is as effective as onabotulinumtoxinA with 60.27% and 61.43% of people responding to treatment, respectively.…”

“…It demonstrated non-inferiority compared to onabotulinum-toxinA in treatment of glabellar lines and crow's feet. 1,2 The safety and efficacy of the neurotoxin was shown to be comparable with onabotulinumtoxinA in poststroke upper limb spasticity 3 and in use for dynamic equinus foot deformities in children with cerebral palsy. 4 This review article summarizes key efficacy and safety studies regarding LeBA.…”

“…LeBA has been studied in treatment of both glabellar lines and crow's feet. It demonstrated non‐inferiority compared to onabotulinumtoxinA in treatment of glabellar lines and crow's feet 1,2 . The safety and efficacy of the neurotoxin was shown to be comparable with onabotulinumtoxinA in poststroke upper limb spasticity 3 and in use for dynamic equinus foot deformities in children with cerebral palsy 4 .…”