Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines

Study Overview
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Brief Summary
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This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.

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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: MBA-P01
* Drug: BOTOX


Participation Criteria
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Eligibility Criteria
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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 can comply with the study procedures and visit schedule Patients who voluntarily sign the informed consent Exclusion Criteria: 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 lines within 6 months Patients who were injected with botulinum toxin within the past 6 months Patients with allergy or hypersensitivity to the investigational drugs or their components 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBA-P01<br>MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1. | Drug: MBA-P01<br>* MBA-P01 will be injected into the Glabellar line.<br>|
| Active Comparator: BOTOX®<br>BOTOX® will be injected into the GL: initial double-blind treatment on Day 1. | Drug: BOTOX<br>* Botox will be injected into the Glabellar line.<br>* Other names: OnabotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-rated improvement rate of glabellar lines at maximum frown | 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 | 
| Participant-rated improvement rate of glabellar lines at maximum frown | 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 | 
| Investigator-rated improvement rate of glabellar lines at rest | 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 | 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 | 
| Independent photo evaluator-rated improvement rate of glabellar lines at frown | 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 | 
| Independent photo evaluator-rated improvement rate of glabellar lines at rest | 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 | Participant evaluate the level of satisfaction by 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied | Week 4, 8, 12, 16 |