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A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic Acid 15% topical gel | Experimental | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
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| Finacea® (azelaic acid) Gel, 15% | Active Comparator | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
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| Placebo | Placebo Comparator | Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic Acid 15% topical gel | Drug | Gel |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 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 |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
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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 |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively
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| Finacea® (azelaic acid) Gel, 15% | Drug | Gel |
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| Placebo | Drug | Gel |
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