Back to resultsMEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
Primary Purpose
Masseter Muscle Hypertrophy
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meditoxin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Masseter Muscle Hypertrophy
Eligibility Criteria
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
Sites / Locations
- Kangbuk Samsung Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MEDITOXIN
Placebo
Arm Description
Outcomes
Primary Outcome Measures
changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
Secondary Outcome Measures
changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03452345
Brief Title
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masseter Muscle Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDITOXIN
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Description
Meditoxin (Botulinum toxin type A)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (Normal saline)
Primary Outcome Measure Information:
Title
changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
Time Frame
12 week follow-up visit
Secondary Outcome Measure Information:
Title
changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline
Time Frame
12 week follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
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