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To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with 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(Botox®) 100 Unit |
|
| Botulinum toxin type A(HG-102) | Experimental | Botulinum toxin type A(HG-102) 100 Unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A Injection [Botox] | Drug | Single administration, Day 0, 20 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event and adverse drug reaction incidence rates | Baseline to week 16 | |
| Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel | 16 weeks (during the clinical trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| Responder rate of improvement in glabellar lines with investigator's photo assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | Korea | 05030 | 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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| Botulinum toxin type A injection [HG-102] | Drug | Single administration, Day 0, 20 units |
|
|
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection |
| Baseline to week 4, 8, 12, 16 |
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| Responder rate of improvement in glabellar lines with investigator's photo assessment | Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| Changes in grade by physician's rating line severity for glabellar lines | Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline | Baseline to week 4, 8, 12, 16 |
| 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, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| Subject's satisfaction rate | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) | The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain)) | Baseline |
| 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 |