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The Effect of Algae Dunaliella Bardawil on Psoriasis (2)

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ClinicalTrials.gov Identifier: NCT01121081
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : May 12, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2010)
  • 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
  • Durability of Response [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Algae Dunaliella Bardawil on Psoriasis (2)
Official Title  ICMJE 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
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.
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Alga Dunaliella Bardawil
    4 capsules per day, 2 in the morning 2 in the evening for 3 month
    Other Name: Active Comparator
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    sugar pills
    Intervention: Drug: Placebo
  • Experimental: Dunaliella
    drug
    Intervention: Drug: Alga Dunaliella Bardawil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2010)
50
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01121081
Other Study ID Numbers  ICMJE SHEBA-09-7464-FP-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Bert W. Strassburger Lipid Center, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Felix Pavlotsky,, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP