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

NCT ID: NCT05964257

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2025-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HU-014

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

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

Interventions

Botulinum toxin type A

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

Intervention Type: DRUG

normal Saline

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huons Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Ang University Hospital

Dongjak, Seoul, South Korea

Countries

South Korea

Other Identifiers

HU-014_P3_BMH

Identifier Type: -

Identifier Source: org_study_id