MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDOTIXN® in Subject With Benign Masseteric Hypertrophy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03452345

Enrollment

180

Registered

2018-03-02

Start date

2018-04-09

Completion date

2019-04-16

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Masseter Muscle Hypertrophy

Brief summary

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

Interventions

DRUGMeditoxin

Meditoxin (Botulinum toxin type A)

DRUGPlacebo

Placebo (Normal saline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline	12 week follow-up visit

Secondary

Measure	Time frame
changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline	12 week follow-up visit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026