Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

Hypertrophy of Masseter Muscle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292472
• Other study ID #: MT_PRT_BMH01
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2014
• Est. completion date: August 24, 2015

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 24, 2015
• Est. primary completion date: May 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy of Masseter Muscle

Intervention

Drug:
• Botulinum Toxin Type A
Inject intramuscularly once in visit 2
• Placebos
Inject intramuscularly once in visit 2

Locations

Country	Name	City	State
Korea, Republic of	Chungang university 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	Reduction amount of masseter muscle thickness		after the injection
Secondary	Reduction amount of masseter muscle thickness and lower face volume		after the injection
Secondary	Overall satisfaction of subject		after the injection