Benign Masseteric HypertrophyPhase 3NCT05964257
To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy
A Phase 3 study testing Botulinum toxin type A and normal Saline in people with Benign Masseteric Hypertrophy, run by Huons Biopharma at 1 site in South Korea.
Trial summary
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Benign Masseteric Hypertrophy
- What is being tested?
- Botulinum toxin type A and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2023to 30 May 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject over 19 years of age and written informed consent is obtained.
- Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.
- Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.
- Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.
- Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.
Who cannot join
- Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
- Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry.
- Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
- Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
- Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
- Subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.)
Show all 9Show fewer
- Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.
- Subject who participate other clinical trials within 4 weeks prior to the study entry.
- Subject 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 Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy.
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy
- Conditions
- Benign Masseteric Hypertrophy
- Being tested
- Botulinum toxin type A, normal Saline
- Keywords
- BMH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
normal SalineDrug
Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| HU-014 | Experimental | Not described Receives: Drug: Botulinum toxin type A |
| Placebo | Placebo comparator | Not described Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Measured: 12weeks
Secondary outcomes (9)
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Measured: 4, 8, 16, 20, 24weeks
Average change from baseline in masseter muscle thickness on both sides at rest
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Measured: 4, 8, 12, 16, 20, 24weeks
Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Measured: 4, 8, 12, 16, 20, 24weeks
Average rate change from baseline in masseter muscle thickness on both sides at rest
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Measured: 4, 8, 12, 16, 20, 24weeks
Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
When measuring, the volume of the lower face was measured twice and the average value was used.
Measured: 4, 8, 12, 16, 20, 24weeks
Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
When measuring, the volume of the lower face was measured twice and the average value was used.
Measured: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.
Overall improvement criteria: +4 (100% complete improvement) ~ -4 (100% very marked worsening)
Measured: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest
Overall satisfaction criteria: grade 1 (very dissatisfied) ~ grade 7 (very satisfied), Grade 6 or higher (satisfied, very satisfied) is evaluated as satisfied.
Measured: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3
MMHS Evaluation criteria: The facial contour and the condition of the bilateral masseter muscles are assessed on a scale from grade 1 (minimal) to grade 5 (very marked).
Measured: 4, 8, 12, 16, 20, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start25 Jul 2023
- Primary completion7 Mar 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Masseteric 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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964257
- Sponsor's protocol ID
- HU-014_P3_BMH
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2023
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy.
- ClinicalTrials.gov ID
- NCT05964257
- Acronym / sponsor ID
- HU-014_P3_BMH
- Conditions
- Benign Masseteric Hypertrophy
- Keywords
- BMH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Huons BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Jul 2023 (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.
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HU-014 | Experimental | Drug: Botulinum toxin type A |
| Placebo | Placebo comparator | Drug: normal 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)
- Male or female subject over 19 years of age and written informed consent is obtained.
- Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.
- Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.
- Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.
- Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.
Key exclusion criteria (9 listed)
- Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
- Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry.
- Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
- Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
- Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
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 ABotulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2. | Drug | HU-014 |
| normal SalineNormal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2. | Drug | Placebo |
Primary outcome
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
Time frame: 12weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
9 secondary outcomes
Average change from baseline in masseter muscle thickness on both sides at maximum clenching
Time frame: 4, 8, 16, 20, 24weeks
Average change from baseline in masseter muscle thickness on both sides at rest
Time frame: 4, 8, 12, 16, 20, 24weeks
Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching
Time frame: 4, 8, 12, 16, 20, 24weeks
Average rate change from baseline in masseter muscle thickness on both sides at rest
Time frame: 4, 8, 12, 16, 20, 24weeks
Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
Time frame: 4, 8, 12, 16, 20, 24weeks
Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging
Time frame: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.
Time frame: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest
Time frame: 4, 8, 12, 16, 20, 24weeks
The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3
Time frame: 4, 8, 12, 16, 20, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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 Botulinum toxin type A and normal Saline in people with Benign Masseteric Hypertrophy, run by Huons Biopharma 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 9 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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?
Results are not available in the source record.
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?
Average change from baseline in masseter muscle thickness on both sides at maximum clenching (time frame: 12weeks). 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 26 Sep 2024.