NCT01628081

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.

Status unknown Phase 3 Last updated 25 June 2012

What this trial tests

Phase 3 trial testing Alga Dunaliella Bardawil placebo in Psoriasis in 46 participants. Status unknown.

Timeline

1 June 2012

Primary endpoint
1 June 2014

1 July 2014

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	46
Start date	1 June 2012
Primary completion	1 June 2014
Estimated completion	1 July 2014
Sites	2 locations across Israel

Drugs / interventions tested

• Alga Dunaliella Bardawil placebo
• Dunaliella Bardawil

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Sheba Medical Center

Who can join

Adults 18 to 75, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Algae-Derived Bioactive Compounds as Platforms for Translational Biotechnology and Health Applications.
   Morris H, Coombes Z, El Dor Z, Rodrigues VJ, et al · · 2026 · PMID 42200944 · DOI 10.3390/biotech15020034