NCT02292472

Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin® in Subjects in Benign Masseteric Hypertrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.

Conditions

• Hypertrophy of Masseter Muscle

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	Inject intramuscularly once in visit 2
DRUG	Placebos	Inject intramuscularly once in visit 2

Timeline

• Start date: 2014-10-06
• Primary completion: 2015-05-24
• Completion: 2015-08-24
• First posted: 2014-11-17
• Last updated: 2019-03-27

Locations

1 site across 1 country: South Korea