Clinical trial NCT01121081: The Effect of Algae Dunaliella Bardawil on Psoriasis (2)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: Male or female subjects
≥18 to ≤75 years of age
who have a diagnosis of plaque or guttate psoriasis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI)75%
timeFrame: 3 month
Secondary outcomes:
measure: PASI 50
timeFrame: 3 month
measure: Durability of Response
timeFrame: 3 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Felix Pavlotsky,, MD
role: PRINCIPAL_INVESTIGATOR
References: