To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

Study Overview
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Brief Summary
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To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.

Official Title
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Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of Botulax® Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines

Conditions
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Skin Aging

Intervention / Treatment
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* Drug: Botulinum toxin type A(Botulax®)
* 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 18 and 65 Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown Patients who voluntarily sign the informed consent Patients who can comply with the study procedures and visit schedule Exclusion Criteria: Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy Subjects with skin disorders, scar or infection around glabellar region Subjects who are taking Aspirin, NSAIDS or anti-coagulant Subjects with facial palsy or eyelid ptosis Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome) Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder) Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months) Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants Subjects who have possibility to take the drugs listed above Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period Subjects who have glabellar lines that are unable to be improved with any physical method Subjects who have history of hypersensitivity to Botulinum toxin and other agents Subjects who are pregnant or breast-feeding Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product Subjects who are having trouble with acute disease Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months Subjects who are unable to communicate or follow the instructions Subjects who are not eligible for this study based on investigator's judgement

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin type A(Botox®)<br>Botulinum toxin type A | Drug: Botulinum toxin type A(Botulax®)<br>* Single administration, Day 0, 20 units<br>|
| Experimental: Botulinum toxin type A (Botulax®)<br>Botulinum toxin type A | Drug: Botulinum toxin type A(Botox®)<br>* Single administration, Day 0, 20units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection. | at 4 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation in experimental drug treatment group |  | 4, 8, 12, 16 weeks post-injection | 
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection. | 8, 12, 16 weeks post-injection | 
| Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity | Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection | 4, 8, 12, 16 weeks post-injection | 
| Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment | Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection | 4, 8, 12, 16 weeks post-injection | 
| Responder rate of improvement in glabellar lines at rest with investigator's photo assessment | Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection | 4, 8, 12, 16 weeks post inejection | 
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection | 4, 8, 12, 16 weeks post-injections | 
| Subject's satisfaction rate | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection | 4, 8, 12, 16 weeks post-injection |