A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

February 22, 2023 updated by: Medytox Korea

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines.

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.
50

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

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
    • Dongjak-gu
      • Seoul, Dongjak-gu, Korea, Republic of, 156-755
        • Chung-And Univ. Hospital

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 19 and 65
  • Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
  • Patients who voluntarily sign the informed consent

Exclusion Criteria:

  • Patients with the history of facial nerve paralysis
  • Patients with the symptoms of eyelid ptosis determined by the investigator
  • Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin, or the inability to substantially lessen glabellar lines even by physically spreading them apart, as determined by the investigator
  • Active skin disease or infection in the treatment area
  • History of surgery which may habe altered the anatomy of the corrugator supercilia muscle or the procerus muscle or related nerve
  • Prior treatment with permanent filers, synthetic implantation, and/or autologous fat transplantation in the treatment area

  • Subject who received the following drugs within 4 weeks prior to the screening

    1. muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants

    2. benzodiazepine: Diazepam, Chlodiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Lorazepam etc.

      • Subject who takes Muscle relaxants and benzodiazepine stably for 4 weeks can participate the study

  • Subject who reveived any of the below facial aesthetic treatments that, in the investigator's opinion, could interfere the evaluation of efficacy

    1. Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.)
    2. Facial resurfacing or skin tightening procedure with lase, light or radiofrequency-based system; or any medium depth or deep depth facial chemical peels in the upper face within 6 months prior to screening

  • Subject who received Retinois following period

    1. Systemic drug delivery : within 6 months prior to the screening
    2. Local drug delivery : within 3 months prior to the screening
  • 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)
  • Known immunization or hypersensitivity to any botulinum toxin preparations
  • Subject who had botulinum toxin treatment within 6 months prior to the screening or planning to receive botulinum toxic treatment during the study period other than study treatment
  • Female subjects who are pregnant or nursing, or planning a pregnancy during the study and female subjects of childbearing potential who are not willing to use acceptable form of sontraception
  • Subject who are participating in other interventional clinical study or have participated in such a study within 30 dyas prior to screening
  • Subjects 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 Assignment
  • 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: MBA-P01
Experimental group, Dose: 20U
Drug: MBA-P01 (Botulinum toxin A)
MBA-P01 will be injected into the Glabellar line
Placebo Comparator: Placebo
Placebo gorup, Normal saline
Drug: Placebo
Placebo will be injected into the Glabellar line

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
Facial Wrinkle Scale(FWS) change
Time Frame: 4 weeks
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
4 weeks

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-rated improvement rate of glabellar lines at maximum frown
Time Frame: Week 8, 12, 16
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Week 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
Time Frame: Week 4, 8, 12, 16
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
Time Frame: Week 4, 8, 12, 16
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
Time Frame: Week 4, 8, 12, 16
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Time Frame: Week 4, 8, 12, 16
Proportion of subject achieving at least 5 score in Participant-rated satisfaction
Week 4, 8, 12, 16

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.
Medytox Korea

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 (Actual)

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 28, 2021

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.
June 22, 2022

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.
June 22, 2022

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).
November 29, 2021

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.
January 26, 2022

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.
February 1, 2022

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.
February 24, 2023

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.
February 22, 2023

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.
February 1, 2023

More Information

Terms related to this study

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.
  • MT14-KR21GBL201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings