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This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBA-P01 | Experimental | MBA-P01 will be injected into GL: |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBA-P01 | Drug | MBA-P01 will be injected into the Glabellar line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments. | Through study completion, an average of 1 year | |
| Incidence rate of TEAE, ADR, SAE and AESI of each cycle | Through each cycle, an average of 3 months | |
| The change of laboratory test and vital sign | Through study completion, an average of 1 year | |
| The result of anti-drug-andibodies (ADA) and neutralizing antibodies | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle | Proportion of paricipants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle |
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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 | 06973 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39462517 | Derived | Han HS, Kim WS, Lee YW, Won CH, Lee W, Choi SY, Kim BJ. Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study. J Dermatolog Treat. 2024 Dec;35(1):2418919. doi: 10.1080/09546634.2024.2418919. Epub 2024 Oct 27. |
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| Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle | Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle |
| Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle | Proportion of participants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle |
| Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle | Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe | at week 4, week 8 and 12 of each cycle |
| Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle | Participant evaluate the level of safisfaction by 7-grade score | at week 4, week 8 and 12 of each cycle |
| Time to retreatment | Through study completion, an average of 1 year |