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To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid foam 15% | Active Comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
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| Finacea® (azelaic acid) Foam, 15% | Active Comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
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| Vehicle of the test product | Placebo Comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid foam 15% | Drug | Azelaic acid foam 15% |
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| Measure | Description | Time Frame |
|---|---|---|
| change in the inflammatory lesion counts | Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catawba Research, LLC | Charlotte | North Carolina | 28217 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C010038 | azelaic acid |
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| Finacea® (Azelaic acid Foam) 15% | Drug | Azelaic acid foam 15% |
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| Vehicle of the test product | Drug | Vehicle of the test product |
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