Status:
COMPLETED
Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
Lead Sponsor:
Medy-Tox
Conditions:
Hypertrophy of Masseter Muscle
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Subject who shows benign masseteric hypertrophy
- Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR.
- Subject who has bisymmetry of masster at visual assessment.
- Subejects who qualifies the standard meets on ultrasonics wave value.
- Subjects who can and will comply with the requirements of the protocol.
Exclusion
- Diagnosis of myasthenia, facial palsy or severe facial asymmetry
- Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year.
- Subject who had previously received botulinum toxin within 3 months prior to the study entry
- Subject who is participating in other investigational study at present or 30 prior to the screening date.
- Subject with known hypersensitivity to botulinum toxin
- Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod.
- Subjects who are not eligible for this study at the discretion of the investigator.
Key Trial Info
Start Date :
October 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02292472
Start Date
October 6 2014
End Date
August 24 2015
Last Update
March 27 2019
Active Locations (1)
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1
Chungang university hospital
Seoul, South Korea