Masseter Muscle HypertrophyPhase 3NCT03452345
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
A Phase 3 study testing Meditoxin in people with Masseter Muscle Hypertrophy, run by Medy-Tox at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Masseter Muscle Hypertrophy
- What is being tested?
- Meditoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Apr 2018to 16 Apr 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject who aged 20 to less than 65 years
- subject with benign masseteric hypertrophy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo
- Conditions
- Masseter Muscle Hypertrophy
- Being tested
- Meditoxin, Placebo
- Medical subject headings
- Masticatory Muscles, Hypertrophy of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditoxinDrug
Meditoxin (Botulinum toxin type A)
PlaceboDrug
Placebo (Normal saline)
| Study group | Role | What they receive |
|---|---|---|
| MEDITOXIN | Experimental | Not described Receives: Drug: Meditoxin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
Measured: 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
Measured: 12 week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start9 Apr 2018
- Primary completion31 Jan 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masseter Muscle HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452345
- Sponsor's protocol ID
- MT01-KR17BMH305
- Status last verified
- Jul 2020
- First submitted
- 26 Feb 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03452345
- Acronym / sponsor ID
- MT01-KR17BMH305
- Conditions
- Masseter Muscle Hypertrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDITOXIN | Experimental | Drug: Meditoxin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject who aged 20 to less than 65 years
- subject with benign masseteric hypertrophy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditoxinMeditoxin (Botulinum toxin type A) | Drug | MEDITOXIN |
| PlaceboPlacebo (Normal saline) | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
Adenoid Hypertrophy, Masseter Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meditoxin in people with Masseter Muscle Hypertrophy, run by Medy-Tox at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.