Status:
TERMINATED
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
Lead Sponsor:
Trima, Israel Pharmaceutical Products
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis.
Eligibility Criteria
Inclusion
- Patients who have been clinically diagnosed as suffering from psoriasis and are or aren't scheduled for Narrow Band Ultraviolet B (UVB)phototherapy of affected areas,excluding face and genitalia.
Exclusion
- 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.
- Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to the beginning of the study.
- Received systemic biologic therapy to treat psoriasis (for example: alefacept, etanercept, infliximab, adalimumab) within 12 weeks prior to the beginning of the study.
- Received systemic psoriasis therapy (for example: methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study.
- Received phototherapy (including laser), photo chemotherapy or climatotherapy within 4 weeks prior to the beginning of the study.
- 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).
- History of noncompliance to medical regimens or unwilling to comply with the study protocol.
- Participation in an investigational drug study within 30 days prior to the beginning of the study.
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01149252
Start Date
January 1 2011
End Date
March 1 2013
Last Update
December 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel