Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.

Detailed Description
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The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.

Official Title
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Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® Versus Botox® in the Treatment of Glabellar Lines

Conditions
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Skin Aging

Intervention / Treatment
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* Drug: Botulinum Toxin Type A(Meditoxin®)
* Drug: Botulinum Toxin Type A(Botox®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 20 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 severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.) Patients who have bleeding tendency or taking anti-coagulant Patients who were injected with botulinum toxin within the past 3 months Patients with allergy or hypersensitivity to the investigational drugs or their components 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 the history of facial nerve paralysis or the symptoms of eyelid ptosis Patients with skin disorders or infection at the injection site Patients who have received other procedures which may affect glabellar and forehead lines within 6 months Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials 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: 20 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: Botulinum toxin type A(Meditoxin®)<br> | Drug: Botulinum Toxin Type A(Meditoxin®)<br>* single administration, Day 0, 20U<br>* Other names: Neuronox®, Siax®;|
| Active Comparator: Botulinum toxin type A(Botox®)<br> | Drug: Botulinum Toxin Type A(Botox®)<br>* single administration, Day 0, 20U<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity | Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection | 0 and 4 weeks after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment | Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection | 0, 8, 12 and 16 weeks after the injection | 
| Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity | Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection | 0, 4, 8, 12 and 16 weeks after the injection | 
| Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment | Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection | 0, 4, 8,12 and 16 weeks after the injection | 
| Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity | Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection | 0, 4, 8, 12 and 16 weeks after the injection | 
| Glabellar line improvement rate confirmed with subject's assessment | Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection | 4, 8, 12 and 16 weeks after the injection | 
| Subject satisfaction rate | Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection | 4, 8, 12 and 16 weeks after the injection |