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The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | blank vehicle formulation |
|
| Dose 1 | Experimental | Dose 1 |
|
| Dose 2 | Experimental | Dose 2 |
|
| Dose 3 | Experimental | Dose 3 |
|
| Dose 4 | Experimental | Dose 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANT-1207 | Biological | single dose application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be assessed by lesion count. | inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Investigator Global Assessment Score | Week 1, 2, 4, 8, and 12 | |
| Change from Baseline in Lesion Count | Week 1, 2, 4, 8, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| International Dermatology Research |
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| Vehicle | Biological |
|
|
| Miami |
| Florida |
| 33144 |
| United States |
| Palm Beach Esthetic Dermatology and Laser Center | West Palm Beach | Florida | 33401 | United States |
| Gwinnett Clinical Research Center Inc. | Snellville | Georgia | 30078 | United States |
| Dermatology Specialists Research, LLC | Louisville | Kentucky | 40202 | United States |
| William Coleman III, MD, APMC | Metairie | Louisiana | 70006 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | United States |
| Gramercy Park Dermatology | New York | New York | 10010 | United States |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Penn State Hershey Medical Center Department of Dermatology | Hershey | Pennsylvania | 17033 | United States |
| Yardley Dermatology Associates | Yardley | Pennsylvania | 19067 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | 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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