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

September 24, 2024 updated by: Huons Biopharma

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
Time Frame: 12weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
12weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
Time Frame: 4, 8, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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.
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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
Time Frame: 4, 8, 12, 16, 20, 24weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huons Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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