The Effect of Algae Dunaliella Bardawil on Psoriasis (2) (NCT01121081) | Clinical Trial Compass
WithdrawnPhase 3
The Effect of Algae Dunaliella Bardawil on Psoriasis (2)
Stopped: no patients enrolled
Israel0Started 2010-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of plaque or guttate psoriasis;
. Psoriasis Area and Severity Index (PASI) score of ≥12 or psoriasis covering ≥10% of body surface area (BSA)
. 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)
. Candidate to phototherapy treatment starting at visit 0.
. For a female subject; either:
Exclusion criteria
. The subject presents with the predominant type of psoriasis as erythrodermic, inverse, pustular or pulmo-plantar or an unstable form of psoriasis;
. Received any investigational drug within 30 days of randomization.
. The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The subject anticipates getting enough extra trial ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
. 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
. 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.
. Personal or first degree relative history of malignant melanoma.