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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Inject intramuscularly once in visit 2
Inject intramuscularly once in visit 2
Chungang university hospital
Seoul, South Korea
Reduction amount of masseter muscle thickness
Time frame: after the injection
Reduction amount of masseter muscle thickness and lower face volume
Time frame: after the injection
Overall satisfaction of subject
Time frame: after the injection
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