Glabellar Frown LinesPhase 3NCT03908008
Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line
A Phase 3 study testing Botox (Botulinum toxin type A) and MT10107 (Botulinum toxin type A) in people with Glabellar Frown Lines, run by Medy-Tox.
Trial summary
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botox (Botulinum toxin type A) and MT10107 (Botulinum toxin type A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2014
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- Men and women aged between 20 and 65
- Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
- Patients who can comply with the study procedures and visit schedule
Who cannot join
- Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
- Patients who have bleeding tendency or taking anti-coagulant
- Patients suffering from acute diseases
- Patients who have been injected with botulinum toxin within past 3 months before the injection
- Patients with allergy or hypersensitivity to the investigational products or their components
- Patients who are pregnant or lactating or found to be pregnant through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
Show all 15Show fewer
- Patients who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, benzodiazepine, aminoglycoside antibiotics, other antibiotics, and anticholinergic drugs.
- Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- Patients with skin damage or infection at the injection site.
- Patients who scheduled a double eyelid operation during the clinical trial.
- Patients who have received or have a plan to receive other procedures, which may affect glabella and forehead lines within 6 months
- Patients whose glabella lines cannot be spread apart even with physical methods like using hands.
- Patients who are participating in other clinical trials or have participated in other clinical trials within 30 days of the screening date.
- Patients who are unable to communicate or follow the instructions
- Patients who are not eligible for this study at the discretion of the investigator
About this study
Official title: A Parallel, Active Drug Controlled, Double Blind, Randomized, Multi-center, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10107 Versus BOTOX® in Treatment of Glabella Line
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.
Read the detailed description
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botox (Botulinum toxin type A), MT10107 (Botulinum toxin type A)
- Keywords
- Glabella line, Glabella lines, Botulinum Toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox (Botulinum toxin type A)Drug
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
MT10107 (Botulinum toxin type A)Drug
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Botox (Botulinum toxin type A) | Active comparator | 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. Receives: Drug: Botox (Botulinum toxin type A); Drug: MT10107 (Botulinum toxin type A) |
| MT10107 (Botulinum toxin type A) | Experimental | 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. Receives: Drug: Botox (Botulinum toxin type A); Drug: MT10107 (Botulinum toxin type A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 4 weeks after the injection.
Measured: 4 weeks after the injection
Secondary outcomes (7)
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 10, 16 weeks after the injection
Measured: 10, 16 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest.
Measured: 4, 10, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at maximum frown
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown at 4 weeks after the injection.
Measured: 4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at rest
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest.
Measured: 4 weeks after the injection
Subject's satisfaction questionnaire to assess treatment efficacy
Subject's satisfaction questionnaire from score 1 to 7, with 7 being the most satisfied, to assess the glabella line improvement at 4, 10, 16 weeks after the injection.
Measured: 4, 10, 16 weeks after the injection
Glabella line improvement rate of subject's assessment
Subject's assessment of glabella line improvement rate at 4, 10, 16 weeks after the injection.
Measured: 4, 10, 16 weeks after the injection
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP from the study start date to the end of study.
Measured: Through study completion, approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study startJan 2014
- Primary completionMay 2014
- Study completionSep 2014
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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huh Changhun, M.D., Study chair, Seoul National University Bundang HospitalYangwon Lee, M.D., Principal investigator, Konkuk University HospitalJonghee Lee, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908008
- Sponsor's protocol ID
- MT_PRT_GL03
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2014
- Last updated
- 10 Apr 2019
- 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 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Active Drug Controlled, Double Blind, Randomized, Multi-center, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10107 Versus BOTOX® in Treatment of Glabella Line
- ClinicalTrials.gov ID
- NCT03908008
- Acronym / sponsor ID
- MT_PRT_GL03
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabella line, Glabella lines, Botulinum Toxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Apr 2019 (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 design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.
Detailed description
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.
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 |
|---|---|---|
| Botox (Botulinum toxin type A) | Active comparator | Drug: Botox (Botulinum toxin type A), Drug: MT10107 (Botulinum toxin type A)20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. |
| MT10107 (Botulinum toxin type A) | Experimental | Drug: Botox (Botulinum toxin type A), Drug: MT10107 (Botulinum toxin type A)20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- Men and women aged between 20 and 65
- Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
- Patients who can comply with the study procedures and visit schedule
Key exclusion criteria (15 listed)
- Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
- Patients who have bleeding tendency or taking anti-coagulant
- Patients suffering from acute diseases
- Patients who have been injected with botulinum toxin within past 3 months before the injection
- Patients with allergy or hypersensitivity to the investigational products 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 |
|---|---|---|
| Botox (Botulinum toxin type A)20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. | Drug | Botox (Botulinum toxin type A), MT10107 (Botulinum toxin type A) |
| MT10107 (Botulinum toxin type A)20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. | Drug | Botox (Botulinum toxin type A), MT10107 (Botulinum toxin type A) |
Primary outcome
Investigator's live assessment of glabella line improvement rate
Time frame: 4 weeks after the injection
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 4 weeks after the injection.
7 secondary outcomes
Investigator's live assessment of glabella line improvement rate
Time frame: 10, 16 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Time frame: 4, 10, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at maximum frown
Time frame: 4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at rest
Time frame: 4 weeks after the injection
Subject's satisfaction questionnaire to assess treatment efficacy
Time frame: 4, 10, 16 weeks after the injection
Glabella line improvement rate of subject's assessment
Time frame: 4, 10, 16 weeks after the injection
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP
Time frame: Through study completion, approximately 8 months
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 10 Apr 2019.
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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.
Huh Changhun, M.D. study chair
Seoul National University Bundang Hospital
Yangwon Lee, M.D. principal investigator
Konkuk University Hospital
Jonghee Lee, M.D. principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox (Botulinum toxin type A) and MT10107 (Botulinum toxin type A) in people with Glabellar Frown Lines, run by Medy-Tox.
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 15 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Investigator's live assessment of glabella line improvement rate (time frame: 4 weeks after the 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 10 Apr 2019.