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To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPSG 7.5% | Experimental | DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days. |
|
| Vehicle Gel | Placebo Comparator | Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days. |
|
| Aczone | Active Comparator | dapsone 7.5 Topical, twice daily on the face for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPSG 7.5% | Drug | topical gel |
|
|
| 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 |
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | 12 weeks |
| 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 | 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 |
|---|---|
| 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 |
|---|---|
| D003622 | Dapsone |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Aczone |
| Drug |
topical gel |
|
|
| Placebo | Drug | topical gel |
|
|