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The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle Gel | Placebo Comparator |
| |
| CLS001 topical gel 1% | Experimental | Topical application once daily |
|
| CLS001 topical gel 1.75% | Experimental | Topical application once daily |
|
| CLS001 topical gel 2.5% | Experimental | Topical application once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS001 Topical Gel | Drug |
| ||
| CLS001 Topical Gel Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion count from Baseline | 6, 9 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions | 1, 3, 6, 9 and 12 weeks | |
| Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions | 1, 3, 6, 9 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encino Research Center | Encino | California | 91436 | United States | ||
| Skin Surgery Medical Group, Inc. |
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| Drug |
|
| Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit | 1, 3, 6, 9, and 12 weeks |
| Percentage of subjects with a 2 grade reduction in the IGA at each visit | 1, 3, 6, 9, and 12 weeks |
| San Diego |
| California |
| 92117 |
| United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | United States |
| Belleair Research Center | Pinellas Park | Florida | 33781 | United States |
| Moore Clinical Research, Inc. | Tampa | Florida | 33609 | United States |
| Kenneth R. Beer, MD, PA | West Palm Beach | Florida | 33401 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Manhattan Dermatology & Cosmetic Center | New York | New York | 10017 | United States |
| Derm Research Center of New York, Inc. | Stony Brook | New York | 11790 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Premier Research | Austin | Texas | 78705 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78229 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | 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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