Clinical trial NCT01628081: The Effect of Alga Dunaliella Bardawil on Psoriasis
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: psoriasis
Alga Dunaliella Bardawil
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-26
Enrollment: 46
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 double blind, parallel group, randomized study with 12 weeks of daily oral administration of Dunaliella or placebo in psoriasis patients.

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 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.

Primary outcomes:
measure: Percent change from baseline (predose day 1) to 18-week period Target Lesion Severity score (TLS) of lesions
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: The Bert W. Strassburger Lipid Center,Sheba Medical Center
city: Tel-Hashomer
country: Israel
facility: The Bert W. Strassburger Lipid Center
Study officials:
affiliation: Sheba Medical Center
name: Shoshana Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: