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| Name | Class |
|---|---|
| Spaulding Clinical Research LLC | OTHER |
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A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB204 4% | Experimental | SB204 4% once |
|
| SB204 8% or 12 % | Experimental | SB204 8 or 12 % (supratherapeutic) once |
|
| Moxifloxacillin | No Intervention | Moxifloxacillin 400 mg orally | |
| Vehicle Gel | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB204 4% | Drug | Applied topically once |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Rico, MD | Novan, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research, LLC | West Bend | Wisconsin | 53095 | United States |
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| 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 |
|---|---|
| C000709171 | berdazimer sodium |
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| SB204 8% or 12% | Drug | Applied once topically |
|
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| Vehicle | Drug | Applied topically once |
|
|