Topical Application of AS101 for the Treatment of Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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Study of Topical Application of AS101 for the Treatment of Psoriasis

Conditions
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Mild to Moderate Psoriasis

Intervention / Treatment
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* Drug: AS101 Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface). Patient must be 18-70 years of age. General health must be adequate to allow for compliance with the requirements of this protocol. Patient or his/her legal guardian must sign an informed consent form prior to study participation. Patient must be able and willing to comply with all protocol requirements. Exclusion Criteria: Patients who are mentally disabled or are otherwise unable to provide fully informed consent. Pregnant or breast-feeding females. Patients with evidence of an infection in the targeted zones. Patients with known sensitivity to any of the drug components. Patients treated by systemic anti psoriatic medications within one month prior to the initial treatment with the AS101, or topical anti psoriatic preparations within two weeks prior to the initial treatment with the AS101. Patient with psoriatic arthritis. Patients taking immunosuppressive drugs. Immunocompromised patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AS101 Cream<br>Twice daily topical application of AS101 cream on the psoriatic lesions for approx. 12 weeks is expected to clear the treated area. | Drug: AS101 Cream<br>* 4% AS101 Cream or Placebo cream, twice a day for 12 weeks<br>|
| Experimental: Placebo<br>Twice daily topical application on the psoriatic lesions for 8 weeks will serve as control group. | Drug: AS101 Cream<br>* 4% AS101 Cream or Placebo cream, twice a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AS101 Psoriasis