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This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E6201 0.005% BID | Experimental | Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
|
| E6201 0.01% BID | Experimental | Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
|
| E6201 0.03% BID | Experimental | Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
|
| E6201 0.03% QD | Experimental | Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6201 0.005% | Drug |
| ||
| E6201 0.01% |
| Measure | Description | Time Frame |
|---|---|---|
| Total Symptom Severity (TSS) at week 8. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK) | Up to 12 weeks |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Eisai US Medical Services | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | United States | ||||
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|
| E6201 0.03% | Drug |
|
| Placebo | Drug |
|
| San Diego |
| California |
| United States |
| Boise | Idaho | United States |
| Champaign | Illinois | United States |
| Clinton Township | Michigan | United States |
| Fridley | Minnesota | United States |
| Omaha | Nebraska | United States |
| Carlstadt | New Jersey | United States |
| Portland | Oregon | United States |
| Austin | Texas | United States |
| College Station | Texas | United States |
| Lynchburg | Virginia | United States |