The Effect of Algae Dunaliella Bardawil on Psoriasis (2)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Alga Dunaliella Bardawil

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: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Placebo Comparator
Experimental: Dunaliella; drug	Drug: Alga Dunaliella Bardawil; 4 capsules per day, 2 in the morning 2 in the evening for 3 month; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)75%	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	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI 50	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	3 month
Durability of Response		3 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Felix Pavlotsky,, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: April 11, 2010
• First Submitted That Met QC Criteria: May 9, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Male or female subjects; ≥18 to ≤75 years of age; who have a diagnosis of plaque or guttate psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: SHEBA-09-7464-FP-CTIL