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This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBA-P01 | Experimental | MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1. |
|
| BOTOX® | Active Comparator | BOTOX® will be injected into the GL: initial double-blind treatment on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBA-P01 | Drug | MBA-P01 will be injected into the Glabellar line. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4. | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated improvement rate of glabellar lines at maximum frown | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 8, 12, 16 |
| Participant-rated improvement rate of glabellar lines at maximum frown |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang Univ. Hospital | Seoul | Dongjak-gu | 156-755 | 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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| BOTOX |
| Drug |
Botox will be injected into the Glabellar line. |
|
|
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. |
| Week 4, 8, 12, 16 |
| Investigator-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 4, 8, 12, 16 |
| Participant-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 4, 8, 12, 16 |
| Independent photo evaluator-rated improvement rate of glabellar lines at frown | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 4, 8, 12, 16 |
| Independent photo evaluator-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. | Week 4, 8, 12, 16 |
| Participant-rated satisfaction after treatment | Participant evaluate the level of satisfaction by 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied | 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 |