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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Benign Masseteric Hypertrophy
• Intervention / Treatment: Drug: Botulinum toxin type A; Drug: normal Saline

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Dongjak, Seoul, Korea, Republic of
      • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: normal Saline; Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Experimental: HU-014	Drug: Botulinum toxin type A; Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4, 8, 16, 20, 24weeks
Average change from baseline in masseter muscle thickness on both sides at rest	The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.	4, 8, 12, 16, 20, 24weeks
Average rate 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.	4, 8, 12, 16, 20, 24weeks
Average rate change from baseline in masseter muscle thickness on both sides at rest	The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.	4, 8, 12, 16, 20, 24weeks
Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging	When measuring, the volume of the lower face was measured twice and the average value was used.	4, 8, 12, 16, 20, 24weeks
Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging	When measuring, the volume of the lower face was measured twice and the average value was used.	4, 8, 12, 16, 20, 24weeks
The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.	Overall improvement criteria: +4 (100% complete improvement) ~ -4 (100% very marked worsening)	4, 8, 12, 16, 20, 24weeks
The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest	Overall satisfaction criteria: grade 1 (very dissatisfied) ~ grade 7 (very satisfied), Grade 6 or higher (satisfied, very satisfied) is evaluated as satisfied.	4, 8, 12, 16, 20, 24weeks
The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3	MMHS Evaluation criteria: The facial contour and the condition of the bilateral masseter muscles are assessed on a scale from grade 1 (minimal) to grade 5 (very marked).	4, 8, 12, 16, 20, 24weeks

Collaborators and Investigators

• Sponsor: Huons Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): March 7, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: BMH
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HU-014_P3_BMH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No