Benign Masseteric HypertrophyPhase 3NCT04294251

Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

A Phase 3 study testing DWP450 in people with Benign Masseteric Hypertrophy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety 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?: DWP450
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteSouth Korea
Study dates: 4 Mar 2020to 10 Aug 2021
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 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 facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
Subject who had previously received botulinum toxin within 12 weeks 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chung-ang University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase Ⅲ Study to Evaluate the Efficacy and Safety of NABOTA® in Subjects With Benign Masseteric Hypertrophy

This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Conditions: Benign Masseteric Hypertrophy
Being tested: DWP450, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DWP450Drug
Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
PlaceboDrug
Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

Study groups in NCT04294251
Study group	Role	What they receive
DWP450	Experimental	Not described Receives: Drug: DWP450
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.

Change from baseline in masseter muscle thickness
Change from baseline in masseter muscle thickness by Ultrasonography
Measured: 12 weeks

Secondary outcomes (3)

Change from baseline in masseter muscle thickness
Change from baseline in masseter muscle thickness by Ultrasonography
Measured: 24 weeks
Change from baseline in lower face volume
Change from baseline in lower face volume by 3D digital imaging
Measured: 24 weeks
Overall satisfaction of subject: questionnaire
Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202010 Aug 2021

First posted4 Mar 2020
Study start4 Mar 2020
Primary completion7 Jan 2021
Study completion10 Aug 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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04294251
Sponsor's protocol ID: DW_DWP450301
Status last verified: Jul 2020
First submitted: 2 Mar 2020
Last updated: 30 Nov 2022
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 30 Nov 2022. 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 NABOTA® in Subjects With Benign Masseteric Hypertrophy
ClinicalTrials.gov ID: NCT04294251
Acronym / sponsor ID: DW_DWP450301
Conditions: Benign Masseteric Hypertrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
Study start: 4 Mar 2020 (actual)
Primary completion: 7 Jan 2021 (actual)
Study completion: 10 Aug 2021 (actual)
First posted: 4 Mar 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 Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 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
DWP450	Experimental	Drug: DWP450
Placebo	Placebo comparator	Drug: Placebo

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 facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
Subject who had previously received botulinum toxin within 12 weeks 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
DWP450Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.	Drug	DWP450
PlaceboPlacebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.	Drug	Placebo

Primary outcome

Change from baseline in masseter muscle thickness
Time frame: 12 weeks
Change from baseline in masseter muscle thickness by Ultrasonography

3 secondary outcomes

Change from baseline in masseter muscle thickness
Time frame: 24 weeks
Change from baseline in lower face volume
Time frame: 24 weeks
Overall satisfaction of subject: questionnaire
Time frame: 24 weeks

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 30 Nov 2022.

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 DWP450 in people with Benign Masseteric Hypertrophy, run by Daewoong Pharmaceutical Co. LTD. 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 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: finished, as of the sponsor's last update on 30 Nov 2022. 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?

Change from baseline in masseter muscle thickness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04294251.

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 30 Nov 2022.