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The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omiganan mid dose | Active Comparator | omiganan mid dose once daily application for 12 weeks |
|
| omiganan high dose | Active Comparator | omiganan high dose once daily application for 12 weeks |
|
| Vehicle group | Placebo Comparator | Vehicle once daily application for 12 weeks |
|
| omiganan low dose | Active Comparator | omiganan low dose once daily application for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omiganan | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion count | 0, 1, 3, 6, 9 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Success on IGA defined as clear or almost clear | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research Inc. | Birmingham | Alabama | 35209 | United States | ||
| ATS Clinical Research |
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| Drug |
|
| Santa Monica |
| California |
| 90404 |
| United States |
| The Savin Center, PC | New Haven | Connecticut | 06511 | United States |
| Skin Care Research, Inc | Boca Raton | Florida | 33486 | United States |
| Dunedin Research Specialists | Dunedin | Florida | 34698 | United States |
| North Florida Dermatology Associates | Jacksonville | Florida | 32204 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Rochester General Medical Group Center for Dermatology at Linden Oaks | Rochester | New York | 14625 | United States |
| Derm Research Center of NY Inc. | Stoney Brook | New York | 11790 | United States |
| Wake Resarch | Raleigh | North Carolina | 27612 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| TriCities Skin and Cancer | Johnson City | Tennessee | 37674 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84117 | United States |
| Virginia Clinical Research Inc. | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625752 | Omiganan |
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