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To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(Botox®) | Active Comparator | Botulinum toxin type A(Botox®) |
|
| Botulinum toxin type A(Hugeltox) | Experimental | Botulinum toxin type A(Hugeltox) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hugeltox | Drug | 1.25U~2.5U/site, Maximum dosage 12.5U~60U/person |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) | at 4 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| (1) Duration of action days | 6 months | |
| (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status | at four weeks post-injection | |
| (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Duck Kim, M.D., Ph.D. | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical Center | Seoul | Seoul | South Korea | |||
| The Catholic University, Seoul, St.Mary's hospital |
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| Botulinum Toxin Type A(Botox®) | Drug | 1.25U~2.5U/site, Maximum dosage 12.5U~60U/person |
|
| at four weeks post-injection |
| (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method) | at four weeks post-injection |
| Seoul |
| Seoul |
| South Korea |
| Cha Hospital | Bundang | South Korea |
| Seoul National University Hospital - Bundang | Bundang | South Korea |
| Youngnam University Hospital | Daegu | South Korea |
| Chungang University Hospital | Seoul | South Korea |
| Kim's eye hospital | Seoul | South Korea |
| The catholic university, Yeouido, St. Mary's hospital | Seoul | South Korea |
| Yeonsei University, Severance hospital - Gangnam | Seoul | South Korea |
| ID | Term |
|---|---|
| C535428 | Benign essential blepharospasm |
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| 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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