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To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perrigo active | Experimental |
| |
| Reference Active | Active Comparator |
| |
| Vehicle control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin Calcium | Drug | mupirocin cream |
| |
| Mupirocin Calcium |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 18 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perrigo Active | Mupirocin Calcium: mupirocin cream |
| FG001 | Reference Active | Mupirocin Calcium: Reference mupirocin cream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2019 | Oct 12, 2022 |
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| Drug |
Reference mupirocin cream |
|
| Vehicle | Drug | vehicle control cream |
|
| FG002 | Vehicle Control | Vehicle: vehicle control cream |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perrigo Active | Mupirocin Calcium: mupirocin cream |
| BG001 | Reference Active | Mupirocin Calcium: Reference mupirocin cream |
| BG002 | Vehicle Control | Vehicle: vehicle control cream |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | Posted | Count of Participants | Participants | 18 days |
|
|
|
|
From Day 1 to Day 17
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Perrigo Active | Mupirocin Calcium: mupirocin cream | 0 | 219 | 0 | 219 | 0 | 219 |
| EG001 | Reference Active | Mupirocin Calcium: Reference mupirocin cream | 0 | 219 | 1 | 219 | 0 | 219 |
| EG002 | Vehicle Control | Vehicle: vehicle control cream | 0 | 219 | 0 | 219 | 0 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Cellulitis and abscess of right lower extremity |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Padagis | 929-502-7291 | jonathan.schwartz@padagis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2021 | Oct 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| 18 to 63 years old |
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| 64 to 75 years old |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|