Hypertrophy of Masseter MusclePhase 2NCT02292472
Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
A Phase 2 study testing Botulinum Toxin Type A in people with Hypertrophy of Masseter Muscle, run by Medy-Tox at 1 site in South Korea.
Trial summary
This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertrophy of Masseter Muscle
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2014to 24 Aug 2015
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who shows benign masseteric hypertrophy
- Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR.
- Subject who has bisymmetry of masster at visual assessment.
- Subejects who qualifies the standard meets on ultrasonics wave value.
- Subjects who can and will comply with the requirements of the protocol.
Who cannot join
- Diagnosis of myasthenia, facial palsy or severe facial asymmetry
- Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year.
- Subject who had previously received botulinum toxin within 3 months prior to the study entry
- Subject who is participating in other investigational study at present or 30 prior to the screening date.
- Subject with known hypersensitivity to botulinum toxin
- Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod.
- Subjects who are not eligible for this study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin® in Subjects in Benign Masseteric Hypertrophy
This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy.
Read the detailed description
Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.
- Conditions
- Hypertrophy of Masseter Muscle
- Being tested
- Botulinum Toxin Type A, Placebos
- Keywords
- masticatory muscles
- 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.
Also called Medytoxin®
Inject intramuscularly once in visit 2
PlacebosDrug
Also called Normal saline
Inject intramuscularly once in visit 2
| Study group | Role | What they receive |
|---|---|---|
| Medytoxin® | Experimental | Botulinum toxin type A Receives: Drug: Botulinum Toxin Type A |
| Normal Saline | Placebo comparator | Normal Saline Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction amount of masseter muscle thickness
Measured: after the injection
Secondary outcomes (2)
Reduction amount of masseter muscle thickness and lower face volume
Measured: after the injection
Overall satisfaction of subject
Measured: after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start6 Oct 2014
- Primary completion24 May 2015
- Study completion24 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophy of Masseter MuscleStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, Ph D, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292472
- Sponsor's protocol ID
- MT_PRT_BMH01
- Status last verified
- Mar 2019
- First submitted
- 12 Nov 2014
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin® in Subjects in Benign Masseteric Hypertrophy
- ClinicalTrials.gov ID
- NCT02292472
- Acronym / sponsor ID
- MT_PRT_BMH01
- Conditions
- Hypertrophy of Masseter Muscle
- Keywords
- masticatory muscles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 24 May 2015 (actual)
- Study completion
- 24 Aug 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy.
Detailed description
Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medytoxin® | Experimental | Drug: Botulinum Toxin Type ABotulinum toxin type A |
| Normal Saline | Placebo comparator | Drug: PlacebosNormal Saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject who shows benign masseteric hypertrophy
- Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR.
- Subject who has bisymmetry of masster at visual assessment.
- Subejects who qualifies the standard meets on ultrasonics wave value.
- Subjects who can and will comply with the requirements of the protocol.
Key exclusion criteria (7 listed)
- Diagnosis of myasthenia, facial palsy or severe facial asymmetry
- Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year.
- Subject who had previously received botulinum toxin within 3 months prior to the study entry
- Subject who is participating in other investigational study at present or 30 prior to the screening date.
- Subject with known hypersensitivity to botulinum toxin
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: Medytoxin®Inject intramuscularly once in visit 2 | Drug | Medytoxin® |
| PlacebosAlso: Normal salineInject intramuscularly once in visit 2 | Drug | Normal Saline |
Primary outcome
Reduction amount of masseter muscle thickness
Time frame: after the injection
2 secondary outcomes
Reduction amount of masseter muscle thickness and lower face volume
Time frame: after the injection
Overall satisfaction of subject
Time frame: after the injection
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 27 Mar 2019.
Related trials for Hypertrophy of Masseter Muscle
RecruitingObservational study
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.
Beom Joon Kim, Ph D principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A in people with Hypertrophy of Masseter Muscle, 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 5 inclusion and 7 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 27 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction amount of masseter muscle thickness (time frame: after the injection). 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 27 Mar 2019.