Benign Masseteric HypertrophyPhase 2NCT04443244
Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
A Phase 2 study testing Botulinum Toxin Type A Injection (Botulax®) 24Units, Botulinum Toxin Type A Injection (Botulax®) 48Units and Botulinum Toxin Type A Injection (Botulax®) 72Units in people with Benign Masseteric Hypertrophy, run by Hugel at 1 site in South Korea.
Trial summary
This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® 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 Injection (Botulax®) 24Units, Botulinum Toxin Type A Injection (Botulax®) 48Units and Botulinum Toxin Type A Injection (Botulax®) 72Units
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2020to 16 Jul 2021
- 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
- Male and Female adults aged 19 or older.
- Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
- Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
- Subject who voluntarily agree to participate in this clinical trial.
Who cannot join
- Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy
Read the detailed description
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy
- Conditions
- Benign Masseteric Hypertrophy
- Being tested
- Botulinum Toxin Type A Injection (Botulax®) 24Units, Botulinum Toxin Type A Injection (Botulax®) 48Units, Botulinum Toxin Type A Injection (Botulax®) 72Units, Botulinum Toxin Type A Injection (Botulax®) 96Units, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A Injection (Botulax®) 24UnitsDrug
Also called Botulax®
Experimental: Botulax® 24Units
Botulinum Toxin Type A Injection (Botulax®) 48UnitsDrug
Also called Botulax®
Experimental: Botulax® 48Units
Botulinum Toxin Type A Injection (Botulax®) 72UnitsDrug
Also called Botulax®
Experimental: Botulax® 72Units
Botulinum Toxin Type A Injection (Botulax®) 96UnitsDrug
Also called Botulax®
Experimental: Botulax® 96Units
Normal SalineOther
Placebo Comparator: Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A(Botulax®) 24Units | Experimental | Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles. Receives: Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units |
| Botulinum Toxin Type A(Botulax®) 48Units | Experimental | Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles. Receives: Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units |
| Botulinum Toxin Type A(Botulax®) 72Units | Experimental | Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles. Receives: Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units |
| Botulinum Toxin Type A(Botulax®) 96Units | Experimental | Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles. Receives: Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units |
| Placebo(Normal Saline) | Placebo comparator | Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of change from baseline in masseter muscle thickness during maximum clenching
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Measured: Baseline to week 12
Secondary outcomes (7)
Amount of change from baseline in masseter muscle thickness during maximum clenching
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Measured: Baseline to week 4, 8, 16
Rate of change from baseline in masseter muscle thickness during maximum clenching
Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Measured: Baseline to week 4, 8, 12, 16
Amount of change from baseline in masseter muscle thickness during resting
Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography
Measured: Baseline to week 4, 8, 12, 16
Rate of change from baseline in masseter muscle thickness during resting
Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography
Measured: Baseline to week 4, 8, 12, 16
Amount and rate of change from baseline in lower face volume during maximum clenching
Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging
Measured: Baseline to week 4, 8, 12, 16
Overall improvement of Investigator
Overall improvement of Investigator by assessment scale
Measured: Baseline to week 4, 8, 12, 16
Overall satisfaction of subject
Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire
Measured: Baseline to week 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start27 May 2020
- Primary completion18 Nov 2020
- Study completion16 Jul 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443244
- Sponsor's protocol ID
- HG-BOTBMH-PII-01
- Status last verified
- Nov 2021
- First submitted
- 12 Jun 2020
- Last updated
- 16 Nov 2021
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
- ClinicalTrials.gov ID
- NCT04443244
- Acronym / sponsor ID
- HG-BOTBMH-PII-01
- Conditions
- Benign Masseteric Hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 23 Jun 2020 (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.
This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy
Detailed description
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A(Botulax®) 24Units | Experimental | Drug: Botulinum Toxin Type A Injection (Botulax®) 24UnitsBotulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles. |
| Botulinum Toxin Type A(Botulax®) 48Units | Experimental | Drug: Botulinum Toxin Type A Injection (Botulax®) 48UnitsBotulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles. |
| Botulinum Toxin Type A(Botulax®) 72Units | Experimental | Drug: Botulinum Toxin Type A Injection (Botulax®) 72UnitsBotulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles. |
| Botulinum Toxin Type A(Botulax®) 96Units | Experimental | Drug: Botulinum Toxin Type A Injection (Botulax®) 96UnitsBotulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles. |
| Placebo(Normal Saline) | Placebo comparator | Other: Normal SalinePlacebo(Normal saline) administered intramuscularly to the bilateral masseter muscles. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female adults aged 19 or older.
- Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
- Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
- Subject who voluntarily agree to participate in this clinical trial.
Key exclusion criteria (3 listed)
- Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.
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 A Injection (Botulax®) 24UnitsAlso: Botulax®Experimental: Botulax® 24Units | Drug | Botulinum Toxin Type A(Botulax®) 24Units |
| Botulinum Toxin Type A Injection (Botulax®) 48UnitsAlso: Botulax®Experimental: Botulax® 48Units | Drug | Botulinum Toxin Type A(Botulax®) 48Units |
| Botulinum Toxin Type A Injection (Botulax®) 72UnitsAlso: Botulax®Experimental: Botulax® 72Units | Drug | Botulinum Toxin Type A(Botulax®) 72Units |
| Botulinum Toxin Type A Injection (Botulax®) 96UnitsAlso: Botulax®Experimental: Botulax® 96Units | Drug | Botulinum Toxin Type A(Botulax®) 96Units |
| Normal SalinePlacebo Comparator: Normal Saline | Other | Placebo(Normal Saline) |
Primary outcome
Amount of change from baseline in masseter muscle thickness during maximum clenching
Time frame: Baseline to week 12
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
7 secondary outcomes
Amount of change from baseline in masseter muscle thickness during maximum clenching
Time frame: Baseline to week 4, 8, 16
Rate of change from baseline in masseter muscle thickness during maximum clenching
Time frame: Baseline to week 4, 8, 12, 16
Amount of change from baseline in masseter muscle thickness during resting
Time frame: Baseline to week 4, 8, 12, 16
Rate of change from baseline in masseter muscle thickness during resting
Time frame: Baseline to week 4, 8, 12, 16
Amount and rate of change from baseline in lower face volume during maximum clenching
Time frame: Baseline to week 4, 8, 12, 16
Overall improvement of Investigator
Time frame: Baseline to week 4, 8, 12, 16
Overall satisfaction of subject
Time frame: Baseline to week 4, 8, 12, 16
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 16 Nov 2021.
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 2 study testing Botulinum Toxin Type A Injection (Botulax®) 24Units, Botulinum Toxin Type A Injection (Botulax®) 48Units and Botulinum Toxin Type A Injection (Botulax®) 72Units in people with Benign Masseteric Hypertrophy, run by Hugel 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 4 inclusion and 3 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 16 Nov 2021. 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?
Amount of change from baseline in masseter muscle thickness during maximum clenching (time frame: Baseline to week 12). 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 16 Nov 2021.