Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

Medytox

Status and phase

Completed

Phase 2

Conditions

Hypertrophy of Masseter Muscle

Treatments

Drug: Botulinum Toxin Type A

Drug: Placebos

Study type

Interventional

Funder types

Industry

Identifiers

NCT02292472

MT_PRT_BMH01

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.