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This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coretox® | Experimental | Botulinum toxin type A to be intramuscularly injected at 4 sites of corrugator muscle and at 1 site of procerus muscle with 0.1 mL (4U) at each site, for a total of 0.5 mL (20U). The administration of the investigational product was performed once at the start of each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORETOX Inj | Biological | Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle | Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild) | At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment). |
| Subject-rated improvement rate of glabellar lines at maximum frown | Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment). | |
| Subject-rated satisfaction at each cycle after treatment | Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment). | |
| Treatment on-set date | From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment). | |
| Treatment duration | From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment). | |
| Number of participants who experienced an adverse event | Baseline to Day 720 | |
| Number of participants with binding and neutralizing antibodies | Screening and Day 720 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| 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 |