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To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(HG102) | Experimental |
| |
| Botulinum toxin type A(Botox®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A Injection [HG102] | Drug | Single administration, Day 0, 20 units |
|
| 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 weeks post injection | Baseline to week 4 |
| 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 investigator's photo assessment at 8, 12, 16 weeks post injection | Baseline to week 8, 12, 16 |
| Responder rate of improvement in glabellar lines with investigator's photo assessment |
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Inclusion Criteria:
Subjects that fit all of the criteria below were selected for this clinical trial.
Exclusion Criteria:
Subjects that fit any of the criteria below were excluded from this clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cho Long Park | Contact | +82-2-6966-1654 | clpark@hugel.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugel | Recruiting | 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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| Botulinum Toxin Type A Injection [Botox] | Drug | Single administration, Day 0, 20 units |
|
|
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 |
| Independent photo evaluator-rated improvement rate of glabellar lines at rest | 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 |
| Participant-rated satisfaction after treatment | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection | Baseline to week 4, 8, 12, 16 |
| 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 |