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This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLPG Topical Gel 1% | Experimental | Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. |
|
| Clindamycin Phosphate Topical Gel 1% | Active Comparator | Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. |
|
| Vehicle of the test product | Placebo Comparator | Placebo (vehicle of the test product), applied to the face twice a day for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLPG Topical Gel 1% | Drug | Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catawba Research, LLC | Charlotte | North Carolina | 28217 | United States |
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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 |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Clindamycin | Drug | Clindamycin Phosphate topical gel 1% |
|
|
| Placebo | Drug | Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |