The Effect of Algae Dunaliella Bardawil on Psoriasis (2)

NCT01121081 | Withdrawn Phase 3

• 1 other identifier: SHEBA-09-7464-FP-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Male or female subjects; ≥18 to ≤75 years of age; who have a diagnosis of plaque or guttate psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  3 month

Secondary Outcomes (2)

• PASI 50

  3 month

• Durability of Response

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

sugar pills

Drug: Placebo

Dunaliella

EXPERIMENTAL

drug

Drug: Alga Dunaliella Bardawil

Interventions

Alga Dunaliella Bardawil DRUG

4 capsules per day, 2 in the morning 2 in the evening for 3 month

Also known as: Active Comparator

Dunaliella

Placebo DRUG

Drug: Alga Dunaliella Bardawil 4 capsules per day, 2 in the morning 2 in the evening for 3 month

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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) \[Exception; subjects with depression that has been adequately controlled for at least 6 months may enroll in the study\];

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Psoriasis; Guttate Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Felix Pavlotsky,, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 11, 2010
• First Posted: May 12, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

IL (1)