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| Name | Class |
|---|---|
| DPT Laboratories, Ltd. | INDUSTRY |
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To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid foam | Experimental |
| |
| Finacea Foam | Active Comparator |
| |
| Placebo Foam | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid foam | Drug |
| ||
| Azelaic acid foam |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change (Reduction) of Lesion Count From Day 1 | Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consultants | High Point | North Carolina | 27262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azelaic Acid Foam | Azelaic acid foam |
| FG001 | Finacea Foam | Azelaic acid foam |
| FG002 | Placebo Foam | Azelaic acid foam - Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azelaic Acid Foam | Azelaic acid foam |
| BG001 | Finacea Foam | Azelaic acid foam |
| 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 | Percent Change (Reduction) of Lesion Count From Day 1 | Posted | Mean | Standard Deviation | percentage of lesion reduction | Day 84 |
|
84 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 | Azelaic Acid Foam | Azelaic acid foam | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director | 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 | Oct 4, 2016 | Oct 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2016 | Oct 16, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
|
| Azelaic acid foam - Placebo | Drug |
|
| BG002 |
| Placebo Foam |
Azelaic acid foam - Placebo |
| 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 |
|
|
|
| 224 |
| 1 |
| 224 |
| 0 |
| 224 |
| EG001 | Finacea Foam | Azelaic acid foam | 0 | 224 | 0 | 224 | 0 | 224 |
| EG002 | Placebo Foam | Azelaic acid foam - Placebo | 0 | 219 | 2 | 219 | 0 | 219 |
| Aseptic Meningitis | Infections and infestations | Non-systematic Assessment |
|
| Major Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
PI's cannot disclose trial results under any circumstances.