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Study has been termination early due to financial contraints.
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The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Tertiary objectives will be to provide visual documentation of the improvement of psoriatic plaques treated with ALT-2074 using digital photography, and to determine the extent of systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of blood concentration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Two psoriatic plaques of similar surface area and severity will be identified for each subject. ALT-2074 will be applied topically twice daily to 1 of the 2 target plaques, and the placebo control to the other plaque for a period of 28 days in amounts sufficient to cover the entire surface area of the target plaque, extending to 1 cm outside of the plaque border. |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4,4-dimethyl-benziso-2H-selenazine | Drug | ALT-2074 in a 0.5% cream formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. | 28 days |
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Inclusion Criteria:
Subjects must meet all of the following criteria to qualify for entry into the study:
Exclusion Criteria:
Any subject who meets any of the following criteria will not qualify for entry into the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ha'emek Medical Center | Afula | Israel | ||||
| Kaplan Medical Center |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo |
| Drug |
Placebo in a cream formulation |
|
| Rehovot |
| Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | Israel |