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To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Brimonidine Topical Gel, 0.33 percent |
|
| Reference Product | Active Comparator | Brimonidine Topical Gel, 0.33 percent (Reference) |
|
| Placebo gel | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Topical Gel, 0.33 percent (Perrigo) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Composite Success | 2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales | Day 15 at hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Composite Success | 2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales | Day 15 at hour 3 |
| Proportion of Subjects With Composite Success |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo) |
| FG001 | Reference Product | Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference) |
| FG002 | Placebo Gel | Placebo Placebo gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo) |
| BG001 | Reference Product | Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (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 | Proportion of Subjects With Composite Success | 2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales | Per protocol population | Posted | Count of Participants | Participants | Day 15 at hour 6 |
|
15 days
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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 | Brimonidine Topical Gel, 0.33 percent Brimonidine Topical Gel, 0.33 percent (Perrigo) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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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 | Mar 19, 2015 | Nov 6, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2015 | Nov 6, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Brimonidine Topical Gel, 0.33 percent (Reference) |
| Drug |
|
|
| Placebo gel | Drug |
|
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales
| Day 15 at hour 9 |
| BG002 | Placebo Gel | Placebo Placebo gel |
| 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 |
|
| Placebo Gel |
Placebo Placebo gel |
|
|
|
| Secondary | Proportion of Subjects With Composite Success | 2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales | Per protocol population | Posted | Count of Participants | Participants | Day 15 at hour 3 |
|
|
|
|
| Secondary | Proportion of Subjects With Composite Success | 2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales | Per protocol population | Posted | Count of Participants | Participants | Day 15 at hour 9 |
|
|
|
|
| 0 |
| 183 |
| 1 |
| 183 |
| 0 |
| 183 |
| EG001 | Reference Product | Brimonidine Topical Gel, 0.33 percent (Reference) Brimonidine Topical Gel, 0.33 percent (Reference) | 0 | 184 | 0 | 184 | 0 | 184 |
| EG002 | Placebo Gel | Placebo Placebo gel | 0 | 185 | 0 | 185 | 0 | 185 |
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