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The objectives of this study are to evaluate the therapeutic equivalence and safety.
The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin and BPO Gel 1.2%/3.75% | Experimental | Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days. |
|
| Onexton™ Gel | Active Comparator | Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days. |
|
| Placebo | Placebo Comparator | Placebo (vehicle of the test product) applied to the face once daily for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% | Drug | Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory 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 defined as an Investigator's Global Assessment score that is at least 2 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 |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Onexton™ Gel | Drug | Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC) |
|
|
| Placebo | Drug | Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |