To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy

NCT05964257 | Active Not Recruiting Phase 3

• 1 other identifier: HU-014_P3_BMH
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy

Conditions

Benign Masseteric Hypertrophy

Keywords

BMH

Outcome Measures

Primary Outcomes (1)

• Average change from baseline in masseter muscle thickness on both sides at maximum clenching

  The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.

  12weeks

Secondary Outcomes (9)

• Average change from baseline in masseter muscle thickness on both sides at maximum clenching

  4, 8, 16, 20, 24weeks

• Average change from baseline in masseter muscle thickness on both sides at rest

  4, 8, 12, 16, 20, 24weeks

• Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching

  4, 8, 12, 16, 20, 24weeks

• Average rate change from baseline in masseter muscle thickness on both sides at rest

  4, 8, 12, 16, 20, 24weeks

• Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging

  4, 8, 12, 16, 20, 24weeks

Study Arms (2)

HU-014

EXPERIMENTAL

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

Drug: normal Saline

Interventions

Botulinum toxin type A DRUG

Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

HU-014

normal Saline DRUG

Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject over 19 years of age and written informed consent is obtained.
• Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.
• Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.
• Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.
• Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.

You may not qualify if:

• Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
• Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry.
• Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
• Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
• Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
• Subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.)
• Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.
• Subject who participate other clinical trials within 4 weeks prior to the study entry.
• Subject who are not eligible for this study at the discretion of the investigator.

Sponsors & Collaborators

• Huons Biopharma: lead

Study Sites (1)

Chung-Ang University Hospital

Dongjak, Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: July 25, 2023
• Primary Completion: March 7, 2024
• Study Completion: May 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

KR (1)