Trial reportAesthetic surgery journal2022
Efficacy and Safety of Letibotulinumtoxin A in the Treatment of Glabellar Lines: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study.
Trial report in Aesthetic surgery journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
10 citing papers in PubMed.
- Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products.Aesthetic plastic surgery · 2026Article
- A 15-Year Computational Twin Modeling Study of Botulinum Toxin A Frequency and Age-Related Facial Aging.Aesthetic plastic surgery · 2026Article
- LetibotulinumtoxinA for Rosacea: A Pilot Study.Toxins · 2026Article
- [Botulinum toxin preparations in dermatology : Characterization, comparison, and treatment options].Dermatologie (Heidelberg, Germany) · 2026Review
- Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study.Annals of dermatology · 2026Article
- A Multimodal Approach to Extended Periorbital Rejuvenation: Clinical Outcomes and Time Course in a Prospective Single-Centre Study.Clinical, cosmetic and investigational dermatology · 2026Article
- Diffusion Characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA, and AbobotulinumtoxinA and its Impact on Muscle Relaxation: A Randomized Split-Face Clinical Trial.Dermatology and therapy · 2025Article
- Real-World Outcomes of a Novel Botulinum Toxin A for Upper Face Aesthetics: Insights From Routine Clinical Practice.Aesthetic surgery journal. Open forum · 2025Article
- A Phase-III Noninferiority, Randomized Controlled Trial of Letibotulinum Toxin A for the Improvement of Moderate-to-Severe Glabellar Wrinkles in China.Plastic and reconstructive surgery. Global open · 2024Article
- Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35 to 50 Years of Age: Post Hoc Analyses of the Phase 3 Clinical Study Data.Aesthetic surgery journal. Open forum · 2024Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLetibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26.
objectivesThe 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.
methodsIn 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.
resultsAt 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.
conclusionsLetibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines. LEVEL OF EVIDENCE: 2:
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