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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Dosage Regimen and Treatment Groups * Daily oral administration of: * Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening). * Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).
Dosage Regimen and Treatment Groups * Daily oral administration of: * Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening). * Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).
The Bert W. Strassburger Lipid Center,Sheba Medical Center
Tel Litwinsky, Israel
RECRUITINGThe Bert W. Strassburger Lipid Center
Tel Litwinsky, Israel
RECRUITINGPercent 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.
Time frame: 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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