Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines

Study Overview
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Brief Summary
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This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines.

Official Title
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A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: MEDITOXIN®


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 the history of facial nerve paralysis or the symptoms of eyelid ptosis Patients who have received other procedures which may affect glabellar and forehead lines within 6 months Patients who have received other procedures which may affect glabellar and forehead lines within 6 months Patients who were injected with botulinum toxin within the past 3 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: 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDITOXIN<br>Meditoxin(Botulinum toxin type A) | Drug: MEDITOXIN®<br>* 20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.<br>* Other names: Neuronox®;|

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 | improvement are defined as subjects with glabellar line severity of none (0) or mild (1). | 4 weeks after final injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment | Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection | 4 weeks after each injection | 
| Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment | Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection | 4 weeks after each injection |