Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05964257
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05964257
Study Brief:
Protocol Section:
NCT05964257