Glabella Line SeverityPhase 2/3NCT03894748
Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
A Phase 2/3 study testing Botulinum Toxin Type A in people with Glabella Line Severity, run by Medy-Tox at 3 sites in South Korea.
Trial summary
This study design is multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabella Line Severity
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Dec 2011to Oct 2012
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Main inclusion criteria
- 1. Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- Other inclusion criteria
- 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 pregnancy through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
Show all 25Show fewer
- All childbearing female subjects, excepting who had amenorrhea over 12 months or sterilization operation(bilateral tubal ligation, bilateral oophorrectomy or hysterectomy), shouldn't be enrolled the study until they tested negative on pregnancy test(urine or serum). The contraceptions which are medically allowable are spermicides, oral contraceptives, barrier method, intrauterine contrace, complete sexual abstinence
- Patients who have been given any of the following drugs within previous 4 weeks at screening
- ① Muscle relaxants: Tubocurarine Chloride, Dantrolene Sodium, baclofen etc.
- ② Spectinomycin HCl
- ③ Aminoglycoside antibiotics: gentamicin sulfate, neomycin sulfate etc.
- ④ Polypeptide antibiotics: Polymyxin B Sulfate etc.
- ⑤ Tetracycline antibiotics
- ⑥ Lincomycin (lincosamides)
- ⑦ Anticholinergic drugs: butylbromide bromide, Trihexyphenidyl HCl etc.
- ⑧ Benzodiazepines and similar drugs: Diazepam, Etizolam etc.
- ⑨ Benzamide drugs: Tiapride HCl, Sulpiride etc.
- 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 have received or have a plan to receive other procedures which may affect glabella and forehead lines within 6 months
- These treatments include soft tissue augmentation in the range of glabella (e.g. hyaluronic acid or collagen-type implants), medium depth peels, facial lifting, dermal photorejuvenation et cetera.
- Patients whose glabella lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
- Patients who are participating in other clinical trials or have participated in other clinical trials within 30days 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Inha University Hospital
Incheon, Jung-gu
The Catholic University of Korea, St. Paul's Hospital
Seoul, Dongdaemun-gu
Kyung Hee University Hospital at Gangdong
Seoul, Kangdong-gu
About this study
Official title: A Parallel, Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10109L Versus BOTOX® in Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
This study design is multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). 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 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 16 weeks.
- Conditions
- Glabella Line Severity
- Being tested
- 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.
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 |
|---|---|---|
| MT10109L(Botulinum toxin type A) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A |
| BOTOX® 50U(Botulinum toxin type A) | Active comparator | Not described Receives: Drug: 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
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
Measured: 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, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown
Measured: 4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest.
Measured: 4 weeks after the injection
Subject's assessment of glabella line improvement rate
Glabella line improvement rate determined by subject's assessment of glabella line severity.
Measured: 4, 10, 16 weeks after the injection
Subject's satisfaction questionnaire
Subject's satisfaction of glabella line improvement at 4, 10, 16 weeks after the injection.
Measured: 4, 10, 16 weeks after the injection
Number of adverse events in subjects
Number of adverse events occuring in all subject for the entire study period.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startDec 2011
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabella Line SeverityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoon Kang, M.D., Principal investigator, Catholic University of Korea Saint Paul's HospitalGwang Seong Choi, M.D., Ph.D., Principal investigator, Inha University HospitalWoo Young Sim, M.D., Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894748
- Sponsor's protocol ID
- MT_PRT_GL02
- Status last verified
- Mar 2019
- First submitted
- 24 Apr 2012
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10109L Versus BOTOX® in Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
- ClinicalTrials.gov ID
- NCT03894748
- Acronym / sponsor ID
- MT_PRT_GL02
- Conditions
- Glabella Line Severity
- Keywords
- Glabella line, Glabella lines, Botulinum Toxin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Mar 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 multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). 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 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 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 |
|---|---|---|
| MT10109L(Botulinum toxin type A) | Experimental | Drug: Botulinum Toxin Type A |
| BOTOX® 50U(Botulinum toxin type A) | Active comparator | Drug: Botulinum Toxin Type A |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Main inclusion criteria
- 1. Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- Other inclusion criteria
Key exclusion criteria (25 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 |
|---|---|---|
| Botulinum Toxin Type A20U 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® 50U(Botulinum toxin type A), MT10109L(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
7 secondary outcomes
Investigator's live assessment of glabella line improvement rate
Time frame: 16 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Time frame: 4, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Time frame: 4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Time frame: 4 weeks after the injection
Subject's assessment of glabella line improvement rate
Time frame: 4, 10, 16 weeks after the injection
Subject's satisfaction questionnaire
Time frame: 4, 10, 16 weeks after the injection
Number of adverse events in subjects
Time frame: Up to 16 weeks
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 28 Mar 2019.
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.
Hoon Kang, M.D. principal investigator
Catholic University of Korea Saint Paul's Hospital
Gwang Seong Choi, M.D., Ph.D. principal investigator
Inha University Hospital
Woo Young Sim, M.D. principal investigator
Kyung Hee University Hospital at Gangdong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum Toxin Type A in people with Glabella Line Severity, run by Medy-Tox at 3 sites 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 6 inclusion and 25 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Mar 2019.