To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy
Benign Masseteric Hypertrophy
About this trial
This is an interventional treatment trial for Benign Masseteric Hypertrophy focused on measuring BMH
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.
Sites / Locations
- Chung-Ang University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
HU-014
Placebo