Glabellar Frown LinesPhase 4NCT03289169
Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines
A Phase 4 study testing MEDITOXIN® in people with Glabellar Frown Lines, run by Medy-Tox at 1 site in South Korea.
Trial summary
This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- MEDITOXIN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2016to 29 May 2019
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 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 and forehead lines within 6 months
- Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- Patients who were injected with botulinum toxin within the past 3 months
- Patients with allergy or hypersensitivity to the investigational drugs or their components
Show all 12Show fewer
- Patients who have bleeding tendency or taking anti-coagulant
- 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 Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line
This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- MEDITOXIN®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDITOXIN®Drug
Also called Neuronox®
20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
| Study group | Role | What they receive |
|---|---|---|
| MEDITOXIN | Experimental | Meditoxin(Botulinum toxin type A) Receives: Drug: MEDITOXIN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
improvement are defined as subjects with glabellar line severity of none (0) or mild (1).
Measured: 4 weeks after final injection
Secondary outcomes (2)
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection
Measured: 4 weeks after each injection
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection
Measured: 4 weeks after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start30 Dec 2016
- Primary completion29 May 2019
- Study completion29 May 2019
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289169
- Sponsor's protocol ID
- MT01-KR16GBL401
- Status last verified
- Aug 2020
- First submitted
- 19 Sep 2017
- Last updated
- 27 Aug 2020
- 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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line
- ClinicalTrials.gov ID
- NCT03289169
- Acronym / sponsor ID
- MT01-KR16GBL401
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 20 Sep 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 evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe 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 |
|---|---|---|
| MEDITOXIN | Experimental | Drug: MEDITOXIN®Meditoxin(Botulinum toxin type A) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 20 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 (12 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 and forehead lines within 6 months
- Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- Patients who were injected with botulinum toxin within the past 3 months
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 |
|---|---|---|
| MEDITOXIN®Also: Neuronox®20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites. | Drug | MEDITOXIN |
Primary outcome
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Time frame: 4 weeks after final injection
improvement are defined as subjects with glabellar line severity of none (0) or mild (1).
2 secondary outcomes
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment
Time frame: 4 weeks after each injection
Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment
Time frame: 4 weeks after each injection
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 27 Aug 2020.
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Glabellar Frown Lines
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 4 study testing MEDITOXIN® in people with Glabellar Frown Lines, run by Medy-Tox 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 12 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 27 Aug 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment (time frame: 4 weeks after final injection). 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 27 Aug 2020.