NCT03452345

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

February 26, 2018

Last Update Submit

July 27, 2020

Conditions

Masseter Muscle Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline

    12 week follow-up visit

Study Arms (2)

MEDITOXIN

EXPERIMENTAL
Drug: Meditoxin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MeditoxinDRUG

Meditoxin (Botulinum toxin type A)

MEDITOXIN
PlaceboDRUG

Placebo (Normal saline)

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject who aged 20 to less than 65 years
  • subject with benign masseteric hypertrophy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Masticatory Muscles, Hypertrophy of

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

April 9, 2018

Primary Completion

January 31, 2019

Study Completion

April 16, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

KR(1)