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

Primary Purpose

Benign Masseteric Hypertrophy

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
normal Saline
Sponsored by
Huons Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Masseteric Hypertrophy focused on measuring BMH

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subject over 19 years of age and written informed consent is obtained. Subject who has bisymmetry of masseter at visual and palpable assessment. Subject who meets thickness of masseter muscle by ultrasonography. Subject who has a scale of benign masseter hypertrophy of 4 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 lower facial 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, Eaton-Lambert 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 with known hypersensitivity to botulinum toxin. 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.

Sites / Locations

  • Chung-Ang University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HU-014

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in masseter muscle thickness
Change from baseline in masseter muscle thickness by Ultrasonography

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
July 26, 2023
Sponsor
Huons Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT05964257
Brief Title
To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 massesric hypertrophy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Masseteric Hypertrophy
Keywords
BMH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HU-014
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Intervention Type
Drug
Intervention Name(s)
normal Saline
Intervention Description
Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Primary Outcome Measure Information:
Title
Change from baseline in masseter muscle thickness
Description
Change from baseline in masseter muscle thickness by Ultrasonography
Time Frame
12week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject over 19 years of age and written informed consent is obtained. Subject who has bisymmetry of masseter at visual and palpable assessment. Subject who meets thickness of masseter muscle by ultrasonography. Subject who has a scale of benign masseter hypertrophy of 4 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 lower facial 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, Eaton-Lambert 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 with known hypersensitivity to botulinum toxin. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ham kiltae
Phone
+82-02-854-4700
Email
kiltae.ham@HUONS.COM
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Dongjak
State/Province
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bum-joon Kim
Phone
+82-2-6299-1718
Email
beomjoon74@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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