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

Huons

Status and phase

Active, not recruiting

Phase 3

Conditions

Benign Masseteric Hypertrophy

Treatments

Drug: normal Saline

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT05964257

HU-014_P3_BMH

Details and patient eligibility

About

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

Enrollment

188 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.