PsoriasisPhase 3NCT01628081
The Effect of Alga Dunaliella Bardawil on Psoriasis
A Phase 3 study testing Dunaliella Bardawil in people with Psoriasis, run by Sheba Medical Center at 2 sites in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Dunaliella Bardawil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2012to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
The Bert W. Strassburger Lipid Center,Sheba Medical Center
Tel HaShomer, 52621
Shoshna Greenberger, MD
- Recruiting
The Bert W. Strassburger Lipid Center
Tel HaShomer, 52621
Ofir Artzi, MD
About this study
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.
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.
- Conditions
- Psoriasis
- Being tested
- Alga Dunaliella Bardawil placebo, Dunaliella Bardawil
- Keywords
- psoriasis, Alga Dunaliella Bardawil
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alga Dunaliella Bardawil placeboDietary supplement
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).
Dunaliella BardawilDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Alga Dunaliella bardawil | Experimental | After screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo. Receives: Dietary Supplement: Dunaliella Bardawil |
| Placebo | Placebo comparator | 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). Receives: Dietary Supplement: Alga Dunaliella Bardawil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shoshana Greenberg, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628081
- Sponsor's protocol ID
- SHEBA-12-9174-SG-CTIL
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01628081
- Acronym / sponsor ID
- SHEBA-12-9174-SG-CTIL
- Conditions
- Psoriasis
- Keywords
- psoriasis, Alga Dunaliella Bardawil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alga Dunaliella bardawil | Experimental | Dietary Supplement: Dunaliella BardawilAfter screen phase of maximum two weeks the subjects will be randomized to one of two treatments groups (1:1): Dunaliella or placebo. |
| Placebo | Placebo comparator | Dietary Supplement: Alga Dunaliella Bardawil placeboDosage 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alga Dunaliella Bardawil placeboDosage 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 | Placebo |
| Dunaliella BardawilDosage 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 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoshana Greenberg, MD principal investigator
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dunaliella Bardawil in people with Psoriasis, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamar Luvish, BSN (972-35303492, tamar.luvish@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.