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MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

NCT ID: NCT03452345

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2019-04-16

Brief Summary

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

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Detailed Description

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Conditions

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Masseter Muscle Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MEDITOXIN

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

Meditoxin (Botulinum toxin type A)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (Normal saline)

Interventions

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Meditoxin

Meditoxin (Botulinum toxin type A)

Intervention Type DRUG

Placebo

Placebo (Normal saline)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT01-KR17BMH305

Identifier Type: -

Identifier Source: org_study_id

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