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This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBA-P01 24U | Experimental | Experimental group; Dose: 24U |
|
| MBA-P01 12U | Experimental | Experimental group; Dose: 12U |
|
| Placebo | Placebo Comparator | Placebo group; normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBA-P01(Botulinum toxin A) | Drug | Intramuscular injection; Dose varies by group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile | Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maroubra Medical Centre | Maroubra | New South Wales | 2035 | Australia |
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| Placebo | Drug | Intramuscular injection; normal saline |
|