Hypertrophy of Masseter Muscle
Conditions
Keywords
masticatory muscles
Brief summary
This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy.
Detailed description
Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.
Interventions
DRUGBotulinum Toxin Type A
Inject intramuscularly once in visit 2
DRUGPlacebos
Inject intramuscularly once in visit 2
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject who shows benign masseteric hypertrophy 2. Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR. 3. Subject who has bisymmetry of masster at visual assessment. 4. Subejects who qualifies the standard meets on ultrasonics wave value. 5. Subjects who can and will comply with the requirements of the protocol.
Exclusion criteria
1. Diagnosis of myasthenia, facial palsy or severe facial asymmetry 2. Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year. 3. Subject who had previously received botulinum toxin within 3 months prior to the study entry 4. Subject who is participating in other investigational study at present or 30 prior to the screening date. 5. Subject with known hypersensitivity to botulinum toxin 6. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod. 7. Subjects who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction amount of masseter muscle thickness | after the injection |
Secondary
| Measure | Time frame |
|---|---|
| Reduction amount of masseter muscle thickness and lower face volume | after the injection |
| Overall satisfaction of subject | after the injection |
Countries
South Korea
Outcome results
None listed