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To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM001 | Experimental | AM001 Cream, 7.5%. 2x daily for 12 weeks. |
|
| Vehicle | Placebo Comparator | Placebo of AM001 Cream. 2x daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AM001 Cream, 7.5% | Drug | Cream, 2x daily for 12 weeks |
| |
| Placebo of AM001 Cream |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment of Disease Severity (IGA) | An overall assessment of disease severity will be performed at each study visit. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Psoriasis Area Severity Index (PASI) | Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit. | 12 Weeks |
| Body Surface Area (BSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States | ||
| Minnesota Clinical Study Center |
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| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
Cream, 2x daily for 12 weeks |
|
The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.
| 12 Weeks |
| Target Lesion Area | The target lesion area will be measured at baseline and each-post-baseline visit. | 12 Weeks |
| Dermatology Life Quality Index (DLQI) | Measured at baseline and week 12. | 12 Weeks |
| Pharmacokinetics | Systemic absorption will be determined in a subgroup. | 2 Weeks |
| Fridley |
| Minnesota |
| 55432 |
| United States |
| Academic Dermatology Association | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| J & S Studies | College Station | Texas | 77845 | United States |