MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

Masseter Muscle Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452345
• Other study ID #: MT01-KR17BMH305
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2018
• Est. completion date: April 16, 2019

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 16, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Masseter Muscle Hypertrophy

Intervention

Drug:
• Meditoxin
Meditoxin (Botulinum toxin type A)
• Placebo
Placebo (Normal saline)

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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