MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

Phase 3CompletedNCT03452345

Medy-Tox180 enrolled

Overview

To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Masseter Muscle Hypertrophy

Interventions

MeditoxinDRUG

Meditoxin (Botulinum toxin type A)

PlaceboDRUG

Placebo (Normal saline)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subject who aged 20 to less than 65 years * subject with benign masseteric hypertrophy Exclusion Criteria: * subject not appropriate for participating in this study according to the investigator's opinion * subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline

Time frame: 12 week follow-up visit

Secondary Outcomes

changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline

Time frame: 12 week follow-up visit

Data from ClinicalTrials.gov

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