Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)

March 27, 2019 updated by: Medy-Tox

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of
        • The Catholic University of Korea, ST. Paul's Hospital
    • Jung-gu
      • Incheon, Jung-gu, Korea, Republic of
        • Inha University Hospital
    • Kangdong-gu
      • Seoul, Kangdong-gu, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

    1. Men and women aged between 20 and 65
    2. Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
    3. Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

  1. Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
  2. Patients who have bleeding tendency or taking anti-coagulant
  3. Patients suffering from acute diseases
  4. Patients who have been injected with botulinum toxin within past 3 months before the injection
  5. Patients with allergy or hypersensitivity to the investigational products or their components

  6. 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

    * 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

  7. 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.
  8. Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
  9. Patients with skin damage or infection at the injection site.

  10. 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.

  11. Patients whose glabella lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
  12. Patients who are participating in other clinical trials or have participated in other clinical trials within 30days of the screening date.
  13. Patients who are unable to communicate or follow the instructions
  14. Patients who are not eligible for this study at the discretion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MT10109L(Botulinum toxin type A)
Drug: 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.
ACTIVE_COMPARATOR: BOTOX® 50U(Botulinum toxin type A)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 weeks after the injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator's live assessment of glabella line improvement rate
Time Frame: 16 weeks after the injection
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown
16 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Time Frame: 4, 16 weeks after the injection
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest.
4, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Time Frame: 4 weeks after the injection
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown
4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate
Time Frame: 4 weeks after the injection
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest.
4 weeks after the injection
Subject's assessment of glabella line improvement rate
Time Frame: 4, 10, 16 weeks after the injection
Glabella line improvement rate determined by subject's assessment of glabella line severity.
4, 10, 16 weeks after the injection
Subject's satisfaction questionnaire
Time Frame: 4, 10, 16 weeks after the injection
Subject's satisfaction of glabella line improvement at 4, 10, 16 weeks after the injection.
4, 10, 16 weeks after the injection
Number of adverse events in subjects
Time Frame: Up to 16 weeks
Number of adverse events occuring in all subject for the entire study period.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medy-Tox

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hoon Kang, M.D., Catholic University of Korea Saint Paul's Hospital
  • Principal Investigator: Gwang Seong Choi, M.D., Ph.D., Inha University Hospital
  • Principal Investigator: Woo Young Sim, M.D., Kyung Hee University Hospital at Gangdong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT_PRT_GL02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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