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The Effect of Alga Dunaliella Bardawil on Psoriasis

This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01628081
First received: June 14, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis
 Dietary Supplement: Alga Dunaliella Bardawil placebo
Dietary Supplement: Dunaliella Bardawil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Percent change from baseline (predose day 1) to 18-week period Target Lesion Severity score (TLS) of lesions [ 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 46
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628081

Contacts
Contact: Tamar Luvish, BSN 972-35303492 tamar.luvish@sheba.health.gov.il

Locations
Israel
The Bert W. Strassburger Lipid Center,Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Principal Investigator: Shoshna Greenberger, MD            
The Bert W. Strassburger Lipid Center Recruiting
Tel-Hashomer, Israel, 52621
Sub-Investigator: Ofir Artzi, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Shoshana Greenberg, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01628081     History of Changes
Other Study ID Numbers: SHEBA-12-9174-SG-CTIL
Study First Received: June 14, 2012
Last Updated: June 25, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
psoriasis
Alga Dunaliella Bardawil

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013