CClinicalTrials.gg
Status unknownNCT01628081Updated Jun 26, 2012

The Effect of Alga Dunaliella Bardawil on Psoriasis

A Phase 3 interventional study of Alga Dunaliella Bardawil placebo and Dunaliella Bardawil in Psoriasis, sponsored by Sheba Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-26.

Sponsored by Sheba Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Psoriasis

Browse trials for

Keywords

  • psoriasis
  • Alga Dunaliella Bardawil
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 46 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Alga Dunaliella bardawil

    After screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo.

    Dietary Supplement: Dunaliella Bardawil

  • Placebo comparator
    Placebo

    Dosage Regimen and Treatment Groups * Daily oral administration of: * Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening). * Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).

    Dietary Supplement: Alga Dunaliella Bardawil placebo

Interventions

  • Dietary supplementAlga Dunaliella Bardawil placebo

    Dosage Regimen and Treatment Groups * Daily oral administration of: * Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening). * Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).

  • Dietary supplementDunaliella Bardawil

    Dosage Regimen and Treatment Groups * Daily oral administration of: * Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening). * Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening).

06

What researchers measure

Primary outcomes

  1. Percent change from baseline (predose day 1) to 18-week period Target Lesion Severity score (TLS) of lesions

    Target lesions will be evaluated for 3 components: erythema, induration, and scaling. Each component will be given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The Target Lesion Severity (TLS) score is calculated as a sum of the 3 components.

    Time frame: 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.

07

Study locations

2 of 2 sites recruiting
  • The Bert W. Strassburger Lipid Center,Sheba Medical Center
    Tel-Hashomer, 52621, Israel
    • Shoshna Greenberger, MD · Principal investigator
    Recruiting
  • The Bert W. Strassburger Lipid Center
    Tel-Hashomer, 52621, Israel
    • Ofir Artzi, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01628081
Lead sponsor
Sheba Medical Center
Responsible party
Sponsor
First posted
Jun 26, 2012
Start date
Jun 2012
Primary completion
Jun 2014 (estimated)
Completion
Jul 2014 (estimated)
Last update
Jun 26, 2012

Study contacts

Tamar Luvish, BSN
Contact
tamar.luvish@sheba.health.gov.il
972-35303492
Shoshana Greenberg, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion