Glabellar Frown LinesPhase 3NCT05321979
Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
A Phase 3 study testing MBA-P01 in people with Glabellar Frown Lines, run by Medytox Korea at 1 site in South Korea.
Trial summary
This study is intended to evaluate long-term safety and efficacy of MBA-P01 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2022to 30 May 2023
- 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
- Patients who completed the phase III trial (MT14-KR20GBL309)
- Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily
Who cannot join
- Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
- Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
- Patient who 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 who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- 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: Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- MBA-P01
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.
| Study group | Role | What they receive |
|---|---|---|
| MBA-P01 | Experimental | MBA-P01 will be injected into GL: Receives: Drug: MBA-P01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments.
Measured: Through study completion, an average of 1 year
Incidence rate of TEAE, ADR, SAE and AESI of each cycle
Measured: Through each cycle, an average of 3 months
The change of laboratory test and vital sign
Measured: Through study completion, an average of 1 year
The result of anti-drug-andibodies (ADA) and neutralizing antibodies
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle
Proportion of paricipants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by investigator
*GL severity: 0=none, 1=mild, 2=moderate, 3=severe
Measured: at week 4, week 8 and 12 of each cycle
Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by investigator
*GL severity: 0=none, 1=mild, 2=moderate, 3=severe
Measured: at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle
Proportion of participants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by participant
*GL severity: 0=none, 1=mild, 2=moderate, 3=severe
Measured: at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by participant
*GL severity: 0=none, 1=mild, 2=moderate, 3=severe
Measured: at week 4, week 8 and 12 of each cycle
Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle
Participant evaluate the level of safisfaction by 7-grade score
Measured: at week 4, week 8 and 12 of each cycle
Time to retreatment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start7 Feb 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 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
- NCT05321979
- Sponsor's protocol ID
- MT14-KR21GBL1202
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han HS, Kim WS, Lee YW, Won CH, Lee W, Choi SY, Kim BJ. Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study. J Dermatolog Treat. 2024 Dec;35(1):2418919. doi: 10.1080/09546634.2024.2418919. Epub 2024 Oct 27.
PubMed 39462517
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05321979
- Acronym / sponsor ID
- MT14-KR21GBL1202
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Medytox KoreaIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Apr 2022 (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 long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBA-P01 | Experimental | Drug: MBA-P01MBA-P01 will be injected into GL: |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who completed the phase III trial (MT14-KR20GBL309)
- Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily
Key exclusion criteria (5 listed)
- Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
- Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
- Patient who 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 who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- Patients who are not eligible for this study based on the judgment of an 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 |
|---|---|---|
| MBA-P01MBA-P01 will be injected into the Glabellar line. | Drug | MBA-P01 |
Primary outcome
Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments.
Time frame: Through study completion, an average of 1 year
Incidence rate of TEAE, ADR, SAE and AESI of each cycle
Time frame: Through each cycle, an average of 3 months
The change of laboratory test and vital sign
Time frame: Through study completion, an average of 1 year
The result of anti-drug-andibodies (ADA) and neutralizing antibodies
Time frame: Through study completion, an average of 1 year
6 secondary outcomes
Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle
Time frame: at week 4, week 8 and 12 of each cycle
Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
Time frame: at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle
Time frame: at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
Time frame: at week 4, week 8 and 12 of each cycle
Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle
Time frame: at week 4, week 8 and 12 of each cycle
Time to retreatment
Time frame: Through study completion, an average of 1 year
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 Jan 2024.
- Derived from this study: PubMed 39462517Han HS, Kim WS, Lee YW, Won CH, Lee W, Choi SY, Kim BJ. Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study. J Dermatolog Treat. 2024 Dec;35(1):2418919. doi: 10.1080/09546634.2024.2418919. Epub 2024 Oct 27.
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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 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 2 inclusion and 5 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 Jan 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. 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?
Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments. (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 NCT05321979, which also lists 1 linked publication.
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 Jan 2024.