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A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HU-014 Inj(Phase 1 and 2) | Experimental | HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) |
|
| Botox Inj(Phase 2) | Active Comparator | Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HU-014 Inj | Biological | Clostridium botulinum type A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) | Week 4 | |
| Change from Baseline of Glabellar Lines improvement rate(Frown) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Columbia Suicide Severity Rating Scale(C-SSRS) | Week 4, Week 8, Week 12 | |
| change from Baseline of Glabellar Lines improvement rate (Frown) | Week 8, Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Seongnam-si | Gyeonggi-do | 13486 | South Korea |
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| Botox Inj |
| Biological |
Clostridium botulinum type A |
|
| change from Baseline of Glabellar Lines improvement rate (Not frown) |
| Week4, Week 8, Week 12 |
| Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment | Week 4, Week 8, Week 12 |
| Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product | Week 4, Week 8, Week 12 |