Glabellar Frown LinesPhase 4NCT04281745
Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®
A Phase 4 study testing CORETOX Inj 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 and efficacy of CORETOX 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?
- CORETOX Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2019to 16 Mar 2022
- 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, Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of Glabellar Lines With CORETOX®
This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- CORETOX Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORETOX InjBiological
Also called Botulinum toxin type A
Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.
| Study group | Role | What they receive |
|---|---|---|
| Coretox® | Experimental | Botulinum toxin type A to be intramuscularly injected at 4 sites of corrugator muscle and at 1 site of procerus muscle with 0.1 mL (4U) at each site, for a total of 0.5 mL (20U). The administration of the investigational product was performed once at the start of each cycle Receives: Biological: CORETOX Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle
Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)
Measured: At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated improvement rate of glabellar lines at maximum frown
Measured: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated satisfaction at each cycle after treatment
Measured: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment on-set date
Measured: From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment duration
Measured: From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Number of participants who experienced an adverse event
Measured: Baseline to Day 720
Number of participants with binding and neutralizing antibodies
Measured: Screening and Day 720
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start17 Oct 2019
- Primary completion17 Jun 2020
- Study completion16 Mar 2022 (estimated)
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
- 200 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
- NCT04281745
- Sponsor's protocol ID
- MT03-KR19GBL404
- Status last verified
- Jul 2020
- First submitted
- 17 Feb 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 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, Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of Glabellar Lines With CORETOX®
- ClinicalTrials.gov ID
- NCT04281745
- Acronym / sponsor ID
- MT03-KR19GBL404
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 16 Mar 2022 (estimated)
- First posted
- 24 Feb 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 evaluates the long-term safety and efficacy of CORETOX 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 |
|---|---|---|
| Coretox® | Experimental | Biological: CORETOX InjBotulinum toxin type A to be intramuscularly injected at 4 sites of corrugator muscle and at 1 site of procerus muscle with 0.1 mL (4U) at each site, for a total of 0.5 mL (20U). The administration of the investigational product was performed once at the start of each cycle |
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 |
|---|---|---|
| CORETOX InjAlso: Botulinum toxin type AClostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline. | Biological | Coretox® |
Primary outcome
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle
Time frame: At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)
Subject-rated improvement rate of glabellar lines at maximum frown
Time frame: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated satisfaction at each cycle after treatment
Time frame: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment on-set date
Time frame: From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment duration
Time frame: From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Number of participants who experienced an adverse event
Time frame: Baseline to Day 720
Number of participants with binding and neutralizing antibodies
Time frame: Screening and Day 720
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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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 4 study testing CORETOX Inj 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: status not confirmed, as of the sponsor's last update on 28 Jul 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?
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?
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle (time frame: At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).). The study lists 7 primary outcomes in all. 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 28 Jul 2020.