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

Consensus Recommendations for Treatment of the Upper Face With LetibotulinumtoxinA. (PubMed, Plast Aesthet Nurs (Phila)) - "The panelists provided recommendations for treating forehead horizontal lines, glabellar frown lines, and lateral canthal lines. The guidelines developed by the panel will support clinical practitioners of all skill levels in providing safe and effective aesthetic treatments of the forehead, glabellar complex, and lateral canthal lines with letibotulinumtoxinA."

Journal • Aesthetic Medicine

Investigating the impact of botulinum toxin type a on the migration of normal human dermal fibroblasts: An in vitro wound healing assay. (PubMed, J Cosmet Dermatol) - "Different types and dilutions of BoNT-A demonstrated variable inhibitory effects on NHDF migration in vitro. The selection of BoNT-A formulation may significantly impact the clinical outcome of scar prevention related to fibroblast migration."

Journal • Preclinical • Fibrosis • Immunology

Comparative Study on the Duration and Efficacy of Various Botulinum Toxin Type A Injections for Reducing Masseteric Muscle Bite Force and Treating Facial Wrinkles. (PubMed, Dermatol Ther (Heidelb)) - "The structural differences among BoNT/A brands did not significantly affect the longevity and efficacy of bite force reduction and wrinkle treatment."

Journal • Aesthetic Medicine

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. (PubMed, Aesthet Surg J Open Forum) - "Response rates remained higher up to Week 16. The treatment demonstrated efficacy and safety in treating vertical glabellar lines in this patient group."

Journal • P3 data • Retrospective data

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials. (PubMed, Dermatol Surg) - "LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome."

Journal • P3 data

Commentary on: Use of LetibotulinumtoxinA for Aesthetic Treatment of Asians: A Consensus. (PubMed, Aesthet Surg J) - No abstract available

Journal • Aesthetic Medicine

"@Channel7 why are you advertising new cosmetic injectable schedule 4 medications on your evening news program as news articles? Your segment on Letybo letibotulinumtoxinA was not news but a bald faced drug advertisement. @TGAgovau @acccgovau" (@tev_mek)

The effect of botulinum toxin type A on normal human dermal fibroblasts in an in vitro wound healing assay (WCD 2023) - "Then, the scratched NHDF monolayer was treated with varying concentrations of 10, 20, 25, 40, 50 and 100 units/milliliter (U/ml) of onabotulinumtoxinA (ONA), letibotulinumtoxinA (LETI), prabotulinumtoxinA (PRABO) and incobotulinumtoxinA (INCO) and 33, 50, 66, 71, 100, 150, 300, and 500 U/ml of abobotulinumtoxinA (ABO). Different types and dilution of BoNT-A provided variable inhibitory effects on fibroblast migration in vitro. The selection of BoNT-A used may influence the clinical outcome for scar prevention"

Late-breaking abstract • Preclinical • Fibrosis • Immunology

Differences in antibody responses of intradermal and intramuscular injections of botulinum toxin type A (WCD 2023) - "MATERIALS AND One hundred subjects were divided into intradermal and intramuscular groups, and each group was equally divided into 5 subgroups for using 5 types of BoNT/A (incobotulinumtoxinA, onabotulinumtoxinA, abobotulinumtoxinA, letibotulinumtoxinA, and prabotulinumtoxinA). Intramuscular BoNT/A injections could be preferable for facial treatment to reduce the antibody against BoNT/A formation"

Botulinum toxin for limb dystonia (Lecture) (ASNA 2023) - No abstract available.

A Multi-center Phase II Study Evaluating the Safety and Efficacy of Botulax® in Asian Patients with Benign Masseteric Hypertrophy. (PubMed, Plast Reconstr Surg) - "BTA administration of at least 48U for BMH is more cost-effective than high-dose units and has a low possibility of side effects."

Journal • P2 data

Use of LetibotulinumtoxinA for Aesthetic Treatment of Asians: A Consensus. (PubMed, Aesthet Surg J) - "Panelists proposed individualized treatment plans for botulinum toxin type A (BTxA) in three aspects of wrinkle removal, contour adjustment, and face lifting in Asians based on their extensive experience and facial anatomy. When using different BTxA, clinicians should start with a conservative dose and carefully individualize the treatment for each patien and adjust it according to the feedback to obtain a higher satisfaction level."

Journal • Aesthetic Medicine

Cosmetic Treatment Using Botulinum Toxin in the Oral and Maxillofacial Area: A Narrative Review of Esthetic Techniques. (PubMed, Toxins (Basel)) - "There are several FDA-approved BoNTs (obabotuli-numtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, letibotulinumtoxinA, prabotulinumtox-inA, daxibotulinumtoxinA, rimbotulinumtoxinB) and novel BoNTs on the market...This paper can serve as a practical illustrative guide and reference for optimal, safe injection areas and effective doses for application of BoNT in the face and oral and maxillofacial area. The history of BoNT indications, contraindications, and complications, and the merits of ultrasonography (US)-assisted injections are also discussed."

Journal • Review • Aesthetic Medicine • Immunology

"Croma Australia Pty Ltd, a subsidiary of Hugel Aesthetics, Receives TGA Approval in Australia for LETYBO (letibotulinumtoxinA) for the Treatment of Glabellar Lines https://t.co/lmtJcYYayN" (@NewsFromBW)

"Hugel Aesthetics Receives FDA Acceptance of BLA Resubmission for LetibotulinumtoxinA for Injection for Glabellar Lines https://t.co/hVw4etBUb4" (@NewsFromBW)

FDA event

Phase 3 Clinical Study of Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines. (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: Hugel

New P3 trial • Immunology

Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Hugel | Not yet recruiting ➔ Completed | Trial completion date: Jul 2020 ➔ Oct 2021 | Trial primary completion date: Jul 2020 ➔ Apr 2021

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Dystonia • Movement Disorders

Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Hugel | Recruiting ➔ Completed | Trial completion date: Jun 2020 ➔ Oct 2021 | Trial primary completion date: Jun 2020 ➔ Apr 2021

Trial completion • Trial completion date • Trial primary completion date • Overactive Bladder

Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines (clinicaltrials.gov) - P3 | N=240 | Completed | Sponsor: Hugel | Recruiting ➔ Completed

Trial completion

Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. (PubMed, Aesthet Surg J) - "Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines."

Clinical • Journal • P3 data

Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea. (PubMed, Toxins (Basel)) - "Four types of BoNTs (prabotulinumtoxin A, onabotulinumtoxin A, neubotulinumtoxin A, and letibotulinumtoxin A) were used in this study. The results showed differences in the total amount of BoNT protein and the cleavage activity of SNAP-25 within all types of BoNTs. The SPR study seemed to be useful for evaluating the potency by specifically measuring intact 19S neurotoxin, and these results provide new insights for assessing different BoNT products."

Journal

Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy (clinicaltrials.gov) - P2; N=80; Completed; Sponsor: Hugel; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ Jul 2021

Clinical • Trial completion • Trial completion date

Time course response after single injection of botulinum toxin to treat spasticity after stroke: systematic review with pharmacodynamic model-based meta-analysis. (PubMed, Ann Phys Rehabil Med) - "This first pharmacodynamic model-based meta-analysis of individuals with stroke revealed that for all BoNT-A preparations, BoNT-A injections to treat spasticity have maximal effect at 5 weeks. The T1/2off was longer for abobotulinumtoxinA than other preparations. Differences between certain BoNT unit scales were also confirmed."

Journal • PK/PD data • Retrospective data • Review • Cardiovascular • CNS Disorders • Movement Disorders • Muscle Spasticity • Vascular Neurology

Botulinum Toxin Type-A (Botulax) Treatment in Patients with Intractable Chronic Occipital Neuralgia: A Pilot Study. (PubMed, Toxins (Basel)) - "There were no adverse events or changes from baseline in serologic studies and vital signs in any of the participants. The treatment's pain-relieving effects were confirmed through regular, 12-week follow-ups, confirming the safety and effectiveness of BTX-A on chronic ON and suggesting that this method is an effective, novel alternative option for chronic ON treatment."

Clinical • Journal • Neuralgia • Pain • Peripheral Neuropathic Pain

Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESS III) (clinicaltrials.gov) - P3; N=355; Completed; Sponsor: Croma-Pharma GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion