The Effect of Alga Dunaliella Bardawil on Psoriasis

A Randomized, Double-Blind, , Placebo Controlled, 18 Week Study To Evaluate the Efficacy of Adjuvant 9-cis-β-Carotene Rich Powder of the Alga Dunaliella Bardawil in Subjects With Plaque Type Psoriasis.

This is a double blind, parallel group, randomized study with 12 weeks of daily oral administration of Dunaliella or placebo in psoriasis patients.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Dietary supplement: Dunaliella Bardawil; Dietary supplement: Alga Dunaliella Bardawil placebo

Detailed Description

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
• Enrollment (Anticipated): 46
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Tel-Hashomer, Israel, 52621
    • Recruiting
    • The Bert W. Strassburger Lipid Center,Sheba Medical Center
    • Principal Investigator: Shoshna Greenberger, MD
  • Tel-Hashomer, Israel, 52621
    • Recruiting
    • The Bert W. Strassburger Lipid Center
    • Sub-Investigator: Ofir Artzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, ≥ 18 to ≤ 75 years of age, who have a diagnosis of plaque or guttate psoriasis;
• Psoriasis covering ≤ 20% of body surface area (BSA)
• Have at least 2 psoriatic plaques measuring 3 cm or more.
• For a female subject; either:
• subject is non-childbearing potential, defined as: menopause with amenorrhea > 2 years, hysterectomy, or bilateral oophorectomy or
• agrees to continue to use adequate contraception (i.e., hormonal [oral, depot, patch], IUD, barrier and spermicide) throughout the study and for at least one month following termination and have a negative urinary pregnancy test at screening and before the first dose of study drug;
• In the opinion of the Investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Exclusion Criteria:

• The subject presents with the predominant type of psoriasis as erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
• Received any investigational drug within 30 days of randomization.
• The subject has not used the following psoriasis treatment for the elaborated periods, prior to the date of screening visit:

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 subject has a known allergy or sensitivity to the study treatment(s) or to any of the percipient contained in the study drug formulation
• Any other acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study;
• Subjects with any laboratory test at screening considered significantly abnormal.

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

• Known serologic positively for human immunodeficiency virus or hepatitis B or hepatitis C virus.
• History of substance abuse, including alcohol abuse, within the past year.
• History or current clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; subjects with depression that has been adequately controlled for at least 6 months may enroll in the study];
• Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study;
• Unwilling or unable to comply with study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alga Dunaliella bardawil; 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).
PLACEBO_COMPARATOR: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Shoshana Greenberg, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): July 1, 2014

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (ESTIMATE): June 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: psoriasis; Alga Dunaliella Bardawil
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: SHEBA-12-9174-SG-CTIL