Affiliation:
1. Tennessee Clinical Research Center , Nashville, TN , USA
2. Center for Clinical and Cosmetic Research , Aventura, FL , USA
3. Perelman Center for Advanced Medicine, University of Pennsylvania , Philadelphia, PA , USA
Abstract
Abstract
Background
Letibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26.
Objectives
The aim of this study was to assess the efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long-term safety and efficacy following repeated injections.
Methods
In this prospective, randomized, parallel-group, double-blind, multicentre, placebo-controlled Phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections of 20 U of letibotulinumtoxin A or placebo. GLS, onset and duration of effect, time to retreatment, and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and the investigator) and an improvement at Week 4 of ≥2 points in GLS score relative to baseline.
Results
At 4 weeks, 78.6% of the active treatment subjects were responders based on the investigator’s assessment and 68.8% based on the subject’s assessment, resulting in a composite responder rate of 64.7% for the active treatment group, whereas the corresponding rate was 0.0% in the placebo group (P < 0.001). Subjects noted a substantial improvement in GL severity as early as Day 2, with the median time to onset of effect being 3 days. The mean [standard deviation] time until first retreatment for the letibotulinumtoxin A group was 127.26 [65.6] days. Letibotulinumtoxin A was well tolerated.
Conclusions
Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.
Level of Evidence: 2
Publisher
Oxford University Press (OUP)
Cited by
3 articles.
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