Benign Masseteric HypertrophyPhase 2NCT03369990
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
A Phase 2 study testing Botulinum toxin type A in people with Benign Masseteric Hypertrophy, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Masseteric Hypertrophy
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject over 18 years of age and written informed consent is obtained.
- Subject with Benign Masseter Hypertrophy
- Subject who has Bisymmetry of masseter at visual assessment.
- Subjects who meets thickness of Masseter muscle by ultrasonography.
- Subjects who can and will comply with the requirements of the protocol.
Who cannot join
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
- Subject who had previously received botulinum toxin within 3 months prior to the study entry
- 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 period.
- Subjects who are not eligible for this study at the discretion of the investigator
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy
This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy
- Conditions
- Benign Masseteric Hypertrophy
- Being tested
- Botulinum toxin type A, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A(DWP450)
PlacebosDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A | Experimental | DWP450 Receives: Drug: Botulinum toxin type A |
| Placebo | 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
Reduction amount of masseter muscle thickness by Ultrasonography
Measured: At 12 weeks
Secondary outcomes (3)
Reduction amount of masseter muscle thickness
Reduction amount of masseter muscle thickness by Ultrasonography
Measured: At 4,8,16 weeks
Reduction amount of lower face volume
Reduction amount of lower face volume by 3D digital imaging
Measured: At 4, 8, 12, 16 weeks
Overall satisfaction of subject
Overall satisfaction of subject by questionnaire
Measured: At 4, 8, 12, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (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.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369990
- Sponsor's protocol ID
- DW_DWP450008
- Status last verified
- Dec 2017
- First submitted
- 26 Nov 2017
- Last updated
- 12 Dec 2017
- 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 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy
- ClinicalTrials.gov ID
- NCT03369990
- Acronym / sponsor ID
- DW_DWP450008
- Conditions
- Benign Masseteric Hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 Dec 2017 (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, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy
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 |
|---|---|---|
| Botulinum toxin type A | Experimental | Drug: Botulinum toxin type ADWP450 |
| Placebo | Placebo comparator | Drug: PlacebosNormal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject over 18 years of age and written informed consent is obtained.
- Subject with Benign Masseter Hypertrophy
- Subject who has Bisymmetry of masseter at visual assessment.
- Subjects who meets thickness of Masseter muscle by ultrasonography.
- Subjects who can and will comply with the requirements of the protocol.
Key exclusion criteria (6 listed)
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
- Subject who had previously received botulinum toxin within 3 months prior to the study entry
- 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 period.
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(DWP450) | Drug | Botulinum toxin type A |
| PlacebosNormal Saline | Drug | Placebo |
Primary outcome
Reduction amount of masseter muscle thickness
Time frame: At 12 weeks
Reduction amount of masseter muscle thickness by Ultrasonography
3 secondary outcomes
Reduction amount of masseter muscle thickness
Time frame: At 4,8,16 weeks
Reduction amount of lower face volume
Time frame: At 4, 8, 12, 16 weeks
Overall satisfaction of subject
Time frame: At 4, 8, 12, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Benign Masseteric Hypertrophy, run by Daewoong Pharmaceutical Co. LTD..
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 6 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Reduction amount of masseter muscle thickness (time frame: At 12 weeks). 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 12 Dec 2017.