Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

Phase 2

Completed

• Conditions: Hypertrophy of Masseter Muscle
• Interventions: Drug: Placebos; Drug: Botulinum Toxin Type A

• Registration Number: NCT02292472
• Lead Sponsor: Medy-Tox

Brief 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.

Study Timeline

• Study Start: 2014-10-06
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Primary Completion: 2015-05-24
• Study Completion: 2015-08-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Subject who shows benign masseteric hypertrophy
2. Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR.
3. Subject who has bisymmetry of masster at visual assessment.
4. Subejects who qualifies the standard meets on ultrasonics wave value.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria

1. Diagnosis of myasthenia, facial palsy or severe facial asymmetry
2. Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year.
3. Subject who had previously received botulinum toxin within 3 months prior to the study entry
4. Subject who is participating in other investigational study at present or 30 prior to the screening date.
5. Subject with known hypersensitivity to botulinum toxin
6. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod.
7. Subjects who are not eligible for this study at the discretion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebos	Normal Saline
Medytoxin®	Botulinum Toxin Type A	Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
Reduction amount of masseter muscle thickness	after the injection

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction of subject	after the injection
Reduction amount of masseter muscle thickness and lower face volume	after the injection

Trial Locations

Locations (1)

Chungang university hospital; 🇰🇷 Seoul, Korea, Republic of