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| Name | Class |
|---|---|
| Sihuan Pharmaceutical Limited | UNKNOWN |
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This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.
The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Botulinum Toxin A type for injection (Botulax®) |
|
| control group | Active Comparator | Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A type for injection (Botulax®) | Drug | Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown)at the site in weeks 1, 8, 12, and 16 after the treatment | weeks 1, 8, 12, and 16 after the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugel Inc. | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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All investigators (investigator, evaluator at each institution, photographer, Independent Evaluation Committee, etc.), except for the injection mixing officer, employees of the sponsor, and test subjects are blinded during the test. Each institution appoints an independent injection formulation officer and prohibits interchange with the drug substance test group to make sure that the blinded method of the test is performed accurately
| Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) | Drug | Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects. |
|
| Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity |
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (when at rest) at the site in weeks 1, 4, 8, 12, and 16 after the treatment |
| weeks 1, 4, 8, 12, and 16 after the treatment |
| Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment | The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (at maximum frown) in weeks 1, 4, 8, 12, and 16 after the treatment | weeks 1, 4, 8, 12, and 16 after the treatment |
| Responder rate of improvement in glabellar lines at rest with investigator's photo assessment | The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (when at rest) in weeks 1, 4, 8, 12, and 16 after the treatment | weeks 1, 4, 8, 12, and 16 after the treatment |
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | The rate of test subjects who self-assess that the treatment is effective (by giving a score of "+2" or higher) in weeks 1, 4, 8, 12, and 16 after the treatment | weeks 1, 4, 8, 12, and 16 after the treatment |
| Subject's satisfaction rate | The rate of test subjects who are satisfied with the treatment effect (test subject's satisfaction rating of 6 - 7) in weeks 1, 4, 8, 12, and 16 after the treatment | weeks 1, 4, 8, 12, and 16 after the treatment |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |