MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

Phase 3

Completed

• Conditions: Masseter Muscle Hypertrophy
• Interventions: Drug: Meditoxin; Drug: Placebo

• Registration Number: NCT03452345
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Study Start: 2018-04-09
• Primary Completion: 2019-01-31
• Study Completion: 2019-04-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDITOXIN	Meditoxin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of