MEDITOXIN® Treatment in Subject With Benign Masseteric Hy... | NCT03452345

Studies
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

NCT03452345

Sponsor

Medy-Tox

Status

Completed

Last Update Posted

Jul 28, 2020Actual

Enrollment

180Actual

Phase

Phase 3

Conditions

Masseter Muscle Hypertrophy

Interventions

Meditoxin
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2018Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Apr 16, 2019Actual

First Submitted Date

Feb 26, 2018

First Submission Date that Met QC Criteria

Feb 26, 2018

First Posted Date

Mar 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MEDITOXIN	Experimental		Drug: Meditoxin
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meditoxin	Drug	Meditoxin (Botulinum toxin type A)	MEDITOXIN
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Hospital		Seoul		03181	South Korea

Condition Browse Module

MeSH Terms

ID	Term
C563600	Masticatory Muscles, Hypertrophy of

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided