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To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(Botox®) | Active Comparator | Botulinum toxin type A |
|
| Botulinum toxin type A (Botulax®) | Experimental | Botulinum toxin type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A(Botulax®) | Drug | Single administration, Day 0, 20 units |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hopspital | Seoul | Dongjak-gu | South Korea | |||
| Seoul National University Hospital |
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| Botulinum toxin type A(Botox®) | Drug | Single administration, Day 0, 20units |
|
| 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 |
| Seoul |
| Jongno-Gu |
| South Korea |
| National Medical Center | Seoul | Jung-Gu | South Korea |
| Eulji General Hospital | Seoul | Nowon-Gu | South Korea |
| The catholic university of Korea, Seoul ST. Mary's Hospital | Seoul | Seocho-Gu | South Korea |
| Korea University Anam Hospital | Seoul | Seongbuk-Gu | South Korea |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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