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To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Padagis active product | Experimental |
| |
| Reference product | Active Comparator |
| |
| Padagis placebo product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roflumilast cream 0.3% | Drug | test product |
| |
| Zoryve |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) | percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1 | Day 1 to Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Research | Louisville | Kentucky | 40241 | United States |
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| Drug |
Reference Listed Drug product |
|
| Placebo | Drug | placebo |
|