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The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and TazoracĀ® (tazarotene cream 0.1%).
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and TazoracĀ® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tazarotene Cream 0.1% | Experimental | Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.) |
|
| TazoracĀ® | Active Comparator | TazoracĀ® (tazarotene cream 0.1%) (Allergan LLC) |
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| Placebo | Placebo Comparator | Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazarotene Cream 0.1% | Drug | Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 |
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |
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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 |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C086827 | tazarotene |
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| TazoracĀ® | Drug | TazoracĀ® applied to lightly cover the entire face once daily for 84 consecutive days. |
|
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| Placebo | Drug | Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days. |
|
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