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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01000714
Date of registration: 22/10/2009
Prospective Registration: Yes
Primary sponsor: Etwal Ltd.
Public title: Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis
Scientific title:
Date of first enrolment: October 2009
Target sample size:
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01000714
Study type:  Interventional
Study design:  N/A  
Phase:  Phase 2
Countries of recruitment
Israel
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Men and women between 18 and 75 years old, inclusive.

2. Clinical diagnosis of psoriasis.

3. In otherwise good general health and free of any disease or physical condition which
might impair evaluation of plaque psoriasis.

4. Able to understand and willing to comply with all study requirements, particularly
the regimen for administration of study drug.

5. Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Women who are pregnant, lactating, planning to become pregnant, or women of
child-bearing potential who have not successfully been using the same medically
acceptable contraceptive methods over the previous 3 months, e.g., oral contraceptive
agents, intrauterine device (IUD), and barrier method plus spermicide.

2. Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids,
or vitamin D analogs) on the areas to be treated within one week prior to the
beginning of the study.

3. Received systemic biologic therapy to treat psoriasis (e.g., alefacept, etanercept,
infliximab, efalizumab, adalimumab) within 12 weeks prior to the beginning of the
study.

4. Received systemic psoriasis therapy (e.g., methotrexate, cyclosporine, systemic
corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning
of the study.

5. Received phototherapy (including laser), photo chemotherapy for the study areas
within 4 weeks prior to the beginning of the study.

6. Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse
will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz
distilled spirits).

7. History of noncompliance to medical regimens or unwilling to comply with the study
protocol.

8. Participation in an investigational drug study within 30 days prior to the beginning
of the study.

9. Serious or unstable medical or psychological conditions that in the opinion of the
Investigator would compromise the subject's safety or successful participation in the
study.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Mild to Moderate Psoriasis
Intervention(s)
Drug: Psirelax
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
protocol No. 1 ver. 1 9-Jan-09
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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