A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe 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 placebo in treatment of glabellar lines.

Official Title
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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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: MBA-P01 (Botulinum toxin A)
* Drug: Placebo


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 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 muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants 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 Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.) 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 Systemic drug delivery : within 6 months prior to the screening 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

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>Experimental group, Dose: 20U | Drug: MBA-P01 (Botulinum toxin A)<br>* MBA-P01 will be injected into the Glabellar line<br>|
| Placebo Comparator: Placebo<br>Placebo gorup, Normal saline | Drug: Placebo<br>* Placebo will be injected into the Glabellar line<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Wrinkle Scale(FWS) change | 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

| 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 | 
| 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 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 | 
| 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 | 
| Participant-rated satisfaction after treatment | Proportion of subject achieving at least 5 score in Participant-rated satisfaction | Week 4, 8, 12, 16 |