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The Effect of Algae Dunaliella Bardawil on Psoriasis (2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121081
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : May 12, 2010
Last Update Posted : January 24, 2013
Information provided by:
Sheba Medical Center

Brief Summary:
This is 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 treated by Narrow Band UVB therapy.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Alga Dunaliella Bardawil Drug: Placebo Phase 3

Detailed Description:

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

Subjects will be screened for eligibility at the baseline visit for phototherapy and blood tests.

After screen phase of maximum two weeks the subjects will be randomized at phototherapy treatment no. 4 in to one of two treatments groups (2:1): Dunaliella or placebo.

Each subject will have a final evaluation 4 weeks after the end of study drug treatment .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Treated by Narrow Band UVB Therapy
Study Start Date : January 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
sugar pills
Drug: Placebo

Drug: Alga Dunaliella Bardawil

4 capsules per day, 2 in the morning 2 in the evening for 3 month

Other Name: Placebo Comparator

Experimental: Dunaliella
Drug: Alga Dunaliella Bardawil
4 capsules per day, 2 in the morning 2 in the evening for 3 month
Other Name: Active Comparator

Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI)75% [ Time Frame: 3 month ]
    Patient disease and skin condition will be assessed using Psoriasis Area and Severity Index and compared to condition on baseline, The PASI score will be calculated at each visit

Secondary Outcome Measures :
  1. PASI 50 [ Time Frame: 3 month ]
    The PASI 50 is an assessment of the proportion of patients who achieve at least 50% improvement in the PASI score from baseline Psoriasis Area and Severity Index (PASI)will be calculated at each visit

  2. Durability of Response [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who meet ALL of the following criteria will be considered for enrollment into this study:

    1. Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations;
    2. Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of plaque or guttate psoriasis;
    3. Psoriasis Area and Severity Index (PASI) score of ≥12 or psoriasis covering ≥10% of body surface area (BSA)
    4. Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale of the National Psoriasis Foundation Psoriasis Score (NPF-PS)
    5. Candidate to phototherapy treatment starting at visit 0.
    6. 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; 7. 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:Subjects who meet ANY of the following criteria will be excluded from participation in this study:

  1. The subject presents with the predominant type of psoriasis as erythrodermic, inverse, pustular or pulmo-plantar or an unstable form of psoriasis;
  2. Received any investigational drug within 30 days of randomization.
  3. The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline:

    Topical psoriasis treatments: 2 weeks Systemic psoriasis treatments: 4 weeks or 5 half lives (whichever is longer) Phototherapy or climatotherapy : 4 weeks Biologic treatments: 4 weeks

  4. The subject anticipates getting enough extra trial ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
  5. The subject has a known allergy or sensitivity to the study treatment(s) or to any of the participant contained in the study drug formulation
  6. 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;
  7. 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 <3.5x10 3/μL; Hgb <10 g/dL; platelets <120x10 3/μL; neutrophils absolute <1.5x10 3/μL; lymphocytes absolute <0.8x10 3/μL) or

  8. Personal or first degree relative history of malignant melanoma.
  9. Known serologic positivity for human immunodeficiency virus or hepatitis B or C virus.
  10. History of substance abuse, including alcohol abuse, within the past year.
  11. 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];
  12. Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study;
  13. Unwilling or unable to comply with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121081

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Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Felix Pavlotsky,, MD Sheba Medical Center
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Responsible Party: The Bert W. Strassburger Lipid Center, Sheba Medical Center Identifier: NCT01121081    
Other Study ID Numbers: SHEBA-09-7464-FP-CTIL
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Sheba Medical Center:
Male or female subjects
≥18 to ≤75 years of age
who have a diagnosis of plaque or guttate psoriasis
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases