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The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of inflammatory lesions rosacea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental |
| |
| Reference product | Active Comparator |
| |
| Placebo product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug |
| ||
| Ivermectin (reference) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | Day 1 to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Clinical Success on the Investigator Global Assessment | Clinical success is defined as a score of clear or almost clear | Day 1 to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Ivermectin cream |
| FG001 | Reference Product | Ivermectin (reference) cream |
| FG002 | Placebo | Placebo cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Ivermectin Cream, 1% (Perrigo) |
| BG001 | Reference Product | Ivermectin Cream, 1% (reference) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion reduction | Day 1 to Day 84 |
|
Day 1 to day 84
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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 | Test Product | Ivermectin cream | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-9900 | jonathan.schwartz@perrigo.com |
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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 | Apr 27, 2016 | Oct 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2016 | Oct 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug |
|
| BG002 |
| Placebo |
Placebo cream |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Subjects With Clinical Success on the Investigator Global Assessment | Clinical success is defined as a score of clear or almost clear | Per protocol population | Posted | Count of Participants | Participants | Day 1 to Day 84 |
|
|
|
|
| 193 |
| 0 |
| 193 |
| 0 |
| 193 |
| EG001 | Reference Product | Ivermectin (reference) cream | 0 | 193 | 0 | 193 | 0 | 193 |
| EG002 | Placebo | Placebo cream | 0 | 100 | 0 | 100 | 0 | 100 |
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