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This is a double blind, parallel group, randomized study with 12 weeks of daily oral administration of Dunaliella or placebo in psoriasis patients.
Subjects will be screened for eligibility at the baseline visit for blood tests.
After screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo.
Each subject will have a final evaluation 4 weeks after the end of study drug treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alga Dunaliella bardawil | Experimental | After screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo. |
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| Placebo | Placebo Comparator | Dosage Regimen and Treatment Groups
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alga Dunaliella Bardawil placebo | Dietary Supplement | Dosage Regimen and Treatment Groups
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline (predose day 1) to 18-week period Target Lesion Severity score (TLS) of lesions | Target lesions will be evaluated for 3 components: erythema, induration, and scaling. Each component will be given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The Target Lesion Severity (TLS) score is calculated as a sum of the 3 components. | Subjects will have study visits at screening- visit 1, randomization - visit 2, after 6 weeks treatment - visit 3, 12 weeks treatment -end of treatment - visit 4 and week 16 - follow up visit 5. |
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Inclusion Criteria:
Exclusion Criteria:
Topical psoriasis treatment, excluding emollients 2-week period Any systemic psoriasis treatment including biologic treatments 4-week or 5-half life time periods (whichever is longer) Phototherapy or Climatotherapy 4-week period
The following will be considered significantly abnormal:
Alanine transaminase (ALT), aspartate transaminase (AST) > 3 upper limit normal. CPK > 3 upper limit normal. Triglycerides > 350mg/dl.
cytopenia (to include any of the following: WBC < 35000/μL; Hgb < 10 g/dL; platelets <120,000/μL; neutrophils absolute < 1500/μL lymphocytes absolute < 800/μL) or
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamar Luvish, BSN | Contact | 972-35303492 | tamar.luvish@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Shoshana Greenberg, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Bert W. Strassburger Lipid Center,Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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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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| ID | Term |
|---|---|
| C076679 | Cbr protein, Dunaliella |
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| Dunaliella Bardawil | Dietary Supplement | Dosage Regimen and Treatment Groups
|
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| The Bert W. Strassburger Lipid Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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