A Phase 3 interventional study of Alga Dunaliella Bardawil placebo and Dunaliella Bardawil in Psoriasis, sponsored by Sheba Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-26.
Sponsored by Sheba Medical Center · Phase 3, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's planned enrollment of 46 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
After screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo.
Dietary Supplement: Dunaliella Bardawil
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).
Dietary Supplement: Alga Dunaliella Bardawil placebo
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).
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.
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.
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheba Medical Center