Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.
This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBA-P01 30U | Experimental | Experimental group, Dose: 30U |
|
| MBA-P01 20U | Experimental | Experimental group, Dose: 20U |
|
| MBA-P01 10U | Experimental | Experimental group, Dose: 10U |
|
| 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 groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial Wrinkle Scale(FWS) change | Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maroubra MEdical Centre | Maroubra | New South Wales | 2035 | Australia |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intramuscular injection |
|
| 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 |