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

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.