Letybo (letibotulinumtoxinA-wlbg) / Hugel, Croma Pharma - LARVOL DELTA

Comments on "Efficacy and Safety of LetibotulinumtoxinA Injection for Trapezius Hypertrophy: A Prospective, Randomized, Double-Blind Trial". (PubMed, Aesthetic Plast Surg) - No abstract available

Clinical • Journal

Botulinum neurotoxin for lip flip. (PubMed, JPRAS Open) - "This short communication describes the anatomical rationale, injection approach, and early clinical observations in three consecutive patients treated with LetybotulinumtoxinA...At two weeks, all patients showed subtle upper lip eversion and reduction of vertical rhytides, with satisfaction ranging from "Satisfied" to "Very Satisfied." No patient reported speech disturbance, difficulty with oral movement, asymmetry, or oral incompetence during the short follow-up. These findings should be interpreted as preliminary because of the very small sample size, lack of control group, absence of blinded assessment, and short follow-up."

Journal

Shoulder contouring with botulinum toxin and fillers. (PubMed, JPRAS Open) - "Because of the very small sample size, lack of a control group, and predominantly qualitative outcome assessment, these observations should not be interpreted as evidence of efficacy, safety, or generalizability. Larger controlled studies with standardized morphometric measurements, validated patient-reported outcome instruments, and longer follow-up are required."

Journal • Aesthetic Medicine

Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain (clinicaltrials.gov) - P4 | N=118 | Completed | Sponsor: PAEC General Hospital, Islamabad

New P4 trial • Fibromyalgia • Musculoskeletal Pain • Pain

LetibotulinumtoxinA for Rosacea: A Pilot Study. (PubMed, Toxins (Basel)) - "Intradermal letibotulinumtoxinA was well tolerated, with few reported side effects/complications. The treatment demonstrated preliminary efficacy in reducing rosacea erythema and flushing, and improving skin physiology and quality of life; however, these require confirmation in a larger, controlled study."

Journal • Dermatology • Pain • Rosacea

Efficacy and Safety of LetibotulinumtoxinA Injection for Trapezius Hypertrophy: A Prospective, Randomized, Double-Blind Trial. (PubMed, Aesthetic Plast Surg) - "LetibotulinumtoxinA for trapezius hypertrophy demonstrated efficacy with no differences between two experimental groups. Aesthetic concerns were addressed, enhancing shoulder and neck appearance with a high degree of satisfaction."

Clinical • Journal

Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure (clinicaltrials.gov) - P=N/A | N=32 | Completed | Sponsor: Yuvell | Active, not recruiting ➔ Completed

Trial completion

Cross-Induction of Anti-Complexing Antibodies in Patients Treated with Botulinum Toxin Formulations Containing Complexing Proteins. (PubMed, Toxins (Basel)) - "One hundred participants were allocated into five treatment groups, each receiving a single BoNT/A formulation: incobotulinumtoxinA (IncoA), onabotulinumtoxinA (OnaA), abobotulinumtoxinA (AboA), letibotulinumtoxinA (LetiA), or prabotulinumtoxinA (PraboA). These findings demonstrate that CP-containing formulations can induce cross-reactive antibody responses, whereas CP-free incobotulinumtoxinA exhibits minimal immunogenicity. This study highlights the importance of CP composition in guiding clinical product selection, particularly in patients requiring repeated BoNT/A administration."

Journal

Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products. (PubMed, Aesthetic Plast Surg) - "Static dose conversion ratios fail to represent the dynamic pharmacodynamic behaviour of BoNT-A formulations. This simulation-based, data-driven approach reproduces clinical outcomes with high fidelity and provides a robust framework for effect-based dose equivalence, improving precision in product substitution and individualized treatment planning."

Journal

Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure (clinicaltrials.gov) - P=N/A | N=34 | Active, not recruiting | Sponsor: Yuvell

New trial

Korean botulinum toxins. (PubMed, J Neural Transm (Vienna)) - "These are PrabotulinumtoxinA (Daewoong/Evolus) and LetibotulinumtoxinA (Hugel/Croma Pharma). There are 12 Class 2 drugs from 10 Korean manufacturers registered in Korea for export and domestic use, including Neuronox®, the first Korean BT drug registered in 2006, NivobotulinumtoxinA/Innotox®, the world-wide first liquid BT type A preparation and Coretox®, the world-wide second BT drug without complexing proteins...5 Korean manufacturers have 5 drug projects in Korea in advanced development phases. With this, Korea is now the country with the worldwide largest number of BT manufacturers and BT drugs."

Journal

A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: Yuvell

New trial

Efficacy and Safety of LetibotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Systematic Review and Meta-Analysis of RCTs. (PubMed, Aesthetic Plast Surg) - "LetibotulinumtoxinA-wlbg is an efficacious and well-tolerated treatment for moderate-to-severe glabellar lines. The therapeutic effect is durable, with statistically significant efficacy maintained at 12 and 16 weeks post-treatment. Treatment results in a significant improvement in patients' psychological well-being related to their facial appearance. The safety profile is favorable, with no statistically significant increase in the risk of serious or non-serious adverse events compared to placebo. Further research, including direct head-to-head trials, is warranted to establish its comparative effectiveness."

Journal • Retrospective data • Review • Aesthetic Medicine

Pilot Retrospective Evaluation of a Balancing and Optimizing Injection Pattern for the Frontalis Muscle Using LetibotulinumtoxinA. (PubMed, Toxins (Basel)) - "These findings suggest that this structured injection approach may offer a consistent method for addressing forehead lines; however, the results should be interpreted within the limitations of a small, uncontrolled retrospective series. Prospective controlled studies with larger populations are needed to further validate the technique."

Journal • Retrospective data

Excipient substitution in botulinum toxin type A formulations: Insights from multi-scale in silico modelling. (PubMed, J Pharm Sci) - "Reformulated PRABO and LETYBO with trehalose-HSA achieved the longest durations (186 ± 8 and 184 ± 9 days), followed by INCO (176 ± 7), ONA (170 ± 8), DAXI (167 ± 10), and ABO (160 ± 7). Reconstitution with 0.5 mL per 100 units minimized spread (1.22 ± 0.04 mm) and maximized persistence (188 ± 9 days, p < 0.01 vs 2.5 mL). Across molecular, mesoscopic, and tissue levels, trehalose-HSA consistently provided superior stability, aggregation resistance, and duration, offering a rational basis for next-generation BoNT/A formulations."

Journal

Hypersensitivity Reactions Associated With Aesthetic Botulinum Toxin A Injections: A Case Series. (PubMed, Cureus) - "In the first case, a 44-year-old woman developed severe angioedema after resuming abobotulinumtoxinA injections following a 12-month pause. Subsequent intradermal tests with onabotulinumtoxinA and incobotulinumtoxinA produced localized reactions, suggesting hypersensitivity to a shared component across formulations, possibly the 150 kDa BoNT/A neurotoxin itself. In the second case, a 38-year-old woman experienced delayed erythema and swelling after letibotulinumtoxinA treatment but tolerated subsequent incobotulinumtoxinA injections, suggesting possible reactivity to complexing proteins or other non-core components rather than the neurotoxin. In the third case, a 50-year-old woman developed systemic symptoms and localized swelling after prabotulinumtoxinA administration, consistent with a delayed-type hypersensitivity reaction...Overall, this case series underscores the importance of clinical vigilance, appropriate patient selection, and awareness of rare but meaningful..."

Journal • Aesthetic Medicine • Cardiovascular • Dermatology • Immunology

Real-World Outcomes of a Novel Botulinum Toxin A for Upper Face Aesthetics: Insights From Routine Clinical Practice. (PubMed, Aesthet Surg J Open Forum) - "Comprehensive upper-face treatment with letibotulinumtoxinA showed meaningful, sustained aesthetic improvement with good tolerability. These findings support further research in larger populations."

Journal • Real-world evidence

High-resolution mass spectrometry and enzyme-linked immunosorbent assay for detection of residual botulinum concentrations in a mouse model of botulism. (PubMed, Leg Med (Tokyo)) - "Our research indicates that under specific sample preparation, chromatographic separation, and untargeted detection conditions, mass spectrometry may not be effective for detecting Botulinum toxin at concentrations below the ng/ml level. The study demonstrates that ELISA is a sensitive and practical alternative for early detection. Positive results can be detected within 2 h of poisoning, especially when taken from muscle tissue."

Journal • Preclinical • CNS Disorders • Dystonia • Movement Disorders • Muscle Spasticity

Computational Model-Informed Comparative Evaluation of Botulinum Toxin A Formulations: A 20-Year Simulation of Onset, Diffusion, Duration, and Immunogenicity. (PubMed, Toxicon) - "LetibotulinumtoxinA and PrabotulinumtoxinA predicted the most balanced profiles, combining high efficacy (mean peak strain reduction 72% and 68%, respectively), rapid onset (2.7-3.1 days), and minimal predicted neutralizing antibody incidence over 20 years (0.4-0.6%). DaxibotulinumtoxinA showed the longest modelled duration of effect (median 142 days), whereas AbobotulinumtoxinA and Relatox exhibited broader diffusion and higher immunogenicity risk...These simulations align closely with available empirical data and suggest that formulation-specific differences in protein structure, diffusion behaviour, and antigenicity may contribute to observed clinical variability. Model-informed comparative analysis can complement real-world and prospective studies to optimize product selection and dosing strategies in aesthetic and therapeutic applications."

Clinical • Journal

Evaluation of the diffusion characteristics of LetibotulinumtoxinA in comparison to Ona- and AbobotulinumtoxinA in a double-blind, randomized split-face study (EADV 2025) - "Therefore, the diffusion characteristics of LetibotulinumtoxinA (Leti-BoNTA), the market leader in South Korea, was compared with OnabotulinumtoxinA (Ona-BoNTA) and AbobotulinumtoxinA (Abo-BoNTA) in a randomized, double-blind, intra- individual split-face comparison. Leti-BoNTA exhibits precise and predictable diffusion while achieving the same clinical efficacy as Ona- and Abo- BoNTA4. Due to the significant differences in diffusion characteristics, treatment protocols should take product- specific behaviour into account, especially when changing formulations. Selection of the appropriate formulation is critical, as diffusion properties can influence therapeutic outcomes."

Clinical • Aesthetic Medicine • Dermatology

A Pilot Study of Differences in Antibody Responses of Intradermal and Intramuscular Injections of Botulinum Toxin Type A. (PubMed, Dermatol Ther (Heidelb)) - "Intradermal injection of BoNT/A appears to elicit a stronger immunogenic response than intramuscular administration, although antibody levels did not reach clinically significant thresholds. These findings underscore the importance of injection technique and interval planning to mitigate immunogenicity. Given the widespread use of intradermal techniques in aesthetic practice, this study provides important clinical insight into optimizing BoNT/A administration."

Journal

A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Yonsei University

New P4 trial

Diffusion Characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA, and AbobotulinumtoxinA and its Impact on Muscle Relaxation: A Randomized Split-Face Clinical Trial. (PubMed, Dermatol Ther (Heidelb)) - "Leti-BoNTA provides wrinkle reduction with a more limited diffusion, as assessed with the Minor's starch-iodine test. Its precise action in this trial implies to be a viable option when controlled spread is essential."

Journal • Aesthetic Medicine

Compensatory Masseteric Bulging: A Novel Observation and Its Implications for Botulinum Neurotoxin Injection Techniques. (PubMed, J Cosmet Dermatol) - "Compensatory bulging underscores the need for holistic treatment addressing the entire muscle. Layered injections, guided by ultrasound and tailored dosing, mitigate asymmetry risks. Clinicians must adopt comprehensive strategies, integrating anatomical insights and advanced imaging, to optimize aesthetic outcomes in masseter hypertrophy management."

Journal

Cross induction of anti-complexing antibodies in botulinum treatment patients injected with botulinum toxin containing complexing proteins (AAD 2025) - "One-hundred participants were divided into 5 subgroups for using 5 types of BoNT/A (incobotulinumtoxinA(IncoA), onabotulinumtoxinA(OnaA), abobotulinumtoxinA(AboA), letibotulinumtoxinA(LetiA), and prabotulinumtoxinA(ProboA). AboA which has difference molecular weight can induce only some type of antibody against CPs. IncoA which do not contain complexing protein is not induced antibody against CPs."

Clinical