CompletedPhase 2

Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

South Korea69 participantsStarted 2014-10-06

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Reduction amount of masseter muscle thickness

Timeframe: after the injection

Trial details

NCT IDNCT02292472

SponsorMedy-Tox

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05-24

View on ClinicalTrials.gov More Hypertrophy of Masseter Muscle trials