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The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI1100 | Experimental | BLI1100 topical cream |
|
| BLI1100 - modified formulation | Experimental | BLI1100 topical cream |
|
| Placebo | Placebo Comparator | Topical cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI1100 | Drug | BLI1100 topical cream |
| |
| BLI1100 - modified formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total lesion count | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total lesion count | Baseline to Week 12 | |
| Investigator's Global Assessment | Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clincal Research | Fremont | California | 94538 | United States | ||
| North Florida Dermatology Associates |
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| Drug |
BLI1100 topical cream |
|
| Placebo | Drug | Placebo topical cream |
|
| Local Tolerability Score | Rating of facial symptoms on a 4 point scale (0=none, 3=severe) | 12 weeks |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Peachtree Dermatology Associates Research Center | Atlanta | Georgia | 30327 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Clinical Partners | Johnston | Rhode Island | 02919 | United States |
| DiscoveResearch | Bryan | Texas | 77802 | United States |
| Suzanne Bruce and Associates | Houston | Texas | 77056 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| The Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | 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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