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The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Omiganan (CLS001) Topical Gel applied once daily |
|
| Vehicle Gel | Placebo Comparator | Vehicle Topical Gel applied once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omiganan (CLS001) Topical Gel | Drug |
| ||
| Vehicle Topical Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in inflammatory lesion counts at week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions | 12 weeks | |
| Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
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|
| Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit | 12 weeks |
| Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit. | 12 weeks |
| Phoenix |
| Arizona |
| United States |
| Santa Ana | California | United States |
| Santa Monica | California | United States |
| Denver | Colorado | United States |
| Boca Raton | Florida | United States |
| Boynton Beach | Florida | United States |
| Miami | Florida | United States |
| Pinellas Park | Florida | United States |
| Sanford | Florida | United States |
| Tampa | Florida | United States |
| Beverly | Massachusetts | United States |
| Fort Gratiot | Michigan | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Newington | New Hampshire | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Stony Brook | New York | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Knoxville | Tennessee | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Pflugerville | Texas | United States |
| San Antonio | Texas | United States |
| Webster | Texas | United States |
| Salt Lake City | Utah | United States |
| Spokane | Washington | United States |
| 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 |
|---|---|
| C000625752 | Omiganan |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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