Glabellar Frown LinesPhase 3NCT05059587
Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines
A Phase 3 study testing MBA-P01 and BOTOX in people with Glabellar Frown Lines, run by Medytox Korea at 1 site in South Korea.
Trial summary
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- MBA-P01 and BOTOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2021to 29 Mar 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who can comply with the study procedures and visit schedule
- Patients who voluntarily sign the informed consent
Who cannot join
- Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- Patients who have received other procedures which may affect glabellar lines within 6 months
- Patients who were injected with botulinum toxin within the past 6 months
- Patients with allergy or hypersensitivity to the investigational drugs or their components
- Patients who have bleeding tendency or taking anti-coagulant
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- Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
- Patients with skin disorders or infection at the injection site
- Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- Patients who are unable to communicate or follow the instructions
- Patients who are not eligible for this study based on the judgment of an investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- MBA-P01, BOTOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBA-P01Drug
MBA-P01 will be injected into the Glabellar line.
BOTOXDrug
Also called OnabotulinumtoxinA
Botox will be injected into the Glabellar line.
| Study group | Role | What they receive |
|---|---|---|
| MBA-P01 | Experimental | MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1. Receives: Drug: MBA-P01 |
| BOTOX® | Active comparator | BOTOX® will be injected into the GL: initial double-blind treatment on Day 1. Receives: Drug: BOTOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4.
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4
Secondary outcomes (7)
Investigator-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Participant evaluate the level of satisfaction by 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied
Measured: 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 posted28 Sep 2021
- Study start30 Aug 2021
- Primary completion29 Dec 2021
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medytox Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059587
- Sponsor's protocol ID
- MT14-KR20GBL309
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05059587
- Acronym / sponsor ID
- MT14-KR20GBL309
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Medytox KoreaIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 28 Sep 2021 (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 intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.
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 |
|---|---|---|
| MBA-P01 | Experimental | Drug: MBA-P01MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1. |
| BOTOX® | Active comparator | Drug: BOTOXBOTOX® will be injected into the GL: initial double-blind treatment on Day 1. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who can comply with the study procedures and visit schedule
- Patients who voluntarily sign the informed consent
Key exclusion criteria (11 listed)
- Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- Patients who have received other procedures which may affect glabellar lines within 6 months
- Patients who were injected with botulinum toxin within the past 6 months
- Patients with allergy or hypersensitivity to the investigational drugs or their components
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 |
|---|---|---|
| MBA-P01MBA-P01 will be injected into the Glabellar line. | Drug | MBA-P01 |
| BOTOXAlso: OnabotulinumtoxinABotox will be injected into the Glabellar line. | Drug | BOTOX® |
Primary outcome
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4.
Time frame: Week 4
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
7 secondary outcomes
Investigator-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 4, 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at frown
Time frame: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Time frame: 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 3 Jun 2022.
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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 MBA-P01 and BOTOX in people with Glabellar Frown Lines, run by Medytox Korea 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 11 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 3 Jun 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. 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?
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4. (time frame: Week 4). 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 3 Jun 2022.