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| ID | Type | Description | Link |
|---|---|---|---|
| CTA Control No. 179120 | Other Identifier | Health Canada | |
| File No. 9427-R1312\1-22C | Other Identifier | Health Canada |
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This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Experimental | Dose A: Botulinum Toxin Type A |
|
| Dose B | Experimental | Dose B: Botulinum Toxin Type A |
|
| Dose C | Experimental | Dose C: Botulinum Toxin Type A |
|
| Dose D | Active Comparator | Dose D: Botulinum Toxin Type A |
|
| Dose E | Placebo Comparator | Dose E: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Intramuscular injection (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown | Week 24 | |
| Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity | Up to Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33065952 | Derived | Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364. | |
| 28614091 |
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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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| Active Comparator botulinum toxin | Biological | IM injection |
|
| Placebo Comparator | Biological | IM injection |
|
| Derived |
| Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206. |
| 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 |