PsoriasisPhase 3NCT01121081
The Effect of Algae Dunaliella Bardawil on Psoriasis (2)
A Phase 3 study testing Alga Dunaliella Bardawil in people with Psoriasis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Alga Dunaliella Bardawil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jan 2012
- 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
- Subjects who meet ALL of the following criteria will be considered for enrollment into this study:
- 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.
Show all 27Show fewer
- 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; 7. 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:Subjects who meet ANY of the following criteria will be excluded from participation in this study:
- 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:
- Topical psoriasis treatments: 2 weeks Systemic psoriasis treatments: 4 weeks or 5 half lives (whichever is longer) Phototherapy or climatotherapy : 4 weeks Biologic treatments: 4 weeks
- 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.
- 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 <3.5x10 3/μL; Hgb <10 g/dL; platelets <120x10 3/μL; neutrophils absolute <1.5x10 3/μL; lymphocytes absolute <0.8x10 3/μL) or
- Personal or first degree relative history of malignant melanoma.
- Known serologic positivity for human immunodeficiency virus or hepatitis B or 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
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 Treated by Narrow Band UVB Therapy
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.
Read the detailed description
This is a double blind, parallel group, randomized study with 12 weeks of daily oral administration of Dunaliella or placebo in psoriasis patients undergoing phototherapy.
Subjects will be screened for eligibility at the baseline visit for phototherapy and blood tests.
After screen phase of maximum two weeks the subjects will be randomized at phototherapy treatment no. 4 in to one of two treatments groups (2:1): 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
- Keywords
- Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of plaque or guttate psoriasis
- Medical subject headings
- Psoriasis, Guttate Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alga Dunaliella BardawilDrug
Also called Active Comparator
4 capsules per day, 2 in the morning 2 in the evening for 3 month
PlaceboDrug
Also called Placebo Comparator
Drug: Alga Dunaliella Bardawil
4 capsules per day, 2 in the morning 2 in the evening for 3 month
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | sugar pills Receives: Drug: Placebo |
| Dunaliella | Experimental | drug Receives: Drug: Alga Dunaliella Bardawil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)75%
Patient disease and skin condition will be assessed using Psoriasis Area and Severity Index and compared to condition on baseline, The PASI score will be calculated at each visit
Measured: 3 month
Secondary outcomes (2)
PASI 50
The PASI 50 is an assessment of the proportion of patients who achieve at least 50% improvement in the PASI score from baseline Psoriasis Area and Severity Index (PASI)will be calculated at each visit
Measured: 3 month
Durability of Response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
Why it stopped: no patients enrolled
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Felix Pavlotsky,, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121081
- Sponsor's protocol ID
- SHEBA-09-7464-FP-CTIL
- Status last verified
- Jan 2013
- First submitted
- 11 Apr 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. 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 Treated by Narrow Band UVB Therapy
- ClinicalTrials.gov ID
- NCT01121081
- Acronym / sponsor ID
- SHEBA-09-7464-FP-CTIL
- Conditions
- Psoriasis
- Keywords
- Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of plaque or guttate psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 12 May 2010 (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 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.
Detailed description
This is a double blind, parallel group, randomized study with 12 weeks of daily oral administration of Dunaliella or placebo in psoriasis patients undergoing phototherapy.
Subjects will be screened for eligibility at the baseline visit for phototherapy and blood tests.
After screen phase of maximum two weeks the subjects will be randomized at phototherapy treatment no. 4 in to one of two treatments groups (2:1): 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebosugar pills |
| Dunaliella | Experimental | Drug: Alga Dunaliella Bardawildrug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects who meet ALL of the following criteria will be considered for enrollment into this study:
- 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; 7. 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:Subjects who meet ANY of the following criteria will be excluded from participation in this study:
- The subject presents with the predominant type of psoriasis as erythrodermic, inverse, pustular or pulmo-plantar or an unstable form of psoriasis;
Key exclusion criteria (0 listed)
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 BardawilAlso: Active Comparator4 capsules per day, 2 in the morning 2 in the evening for 3 month | Drug | Dunaliella |
| PlaceboAlso: Placebo ComparatorDrug: Alga Dunaliella Bardawil 4 capsules per day, 2 in the morning 2 in the evening for 3 month | Drug | Placebo |
Primary outcome
Psoriasis Area and Severity Index (PASI)75%
Time frame: 3 month
Patient disease and skin condition will be assessed using Psoriasis Area and Severity Index and compared to condition on baseline, The PASI score will be calculated at each visit
2 secondary outcomes
PASI 50
Time frame: 3 month
Durability of Response
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Felix Pavlotsky,, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alga Dunaliella Bardawil in people with Psoriasis, run by Sheba Medical Center at 1 site 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 27 inclusion and 0 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: withdrawn, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI)75% (time frame: 3 month). 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 24 Jan 2013.