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Sponsor's considerations
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This protocol relates to a phase II randomized double blind, placebo controlled study of the AS101 topical application for the treatment of mild to moderate Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS101 Cream | Experimental | Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area. |
|
| Placebo | Experimental | Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS101 Cream | Drug | 4% AS101 Cream or Placebo cream, twice a day for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the percentege of patients in which modified PASI (mPASI) score reduction of more than 66% from Baseline whithin 12-week treatment period is achieved | 12 weeks treatment and 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| The main secondary endpoints are to evaluate safety, tolerability of topical AS010 treatment and long term remission of psoriasis. | 12 weeks treatment and 3 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arie Ingbar, Prof | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | Israel |
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