Psoriasis
Conditions
Keywords
Psoriasis
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.
Interventions
OTHERPsoralait
Cream to be used as instructed.
OTHERPlacebo cream.
Cream to be used as instructed
Sponsors
Trima, Israel Pharmaceutical Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index (PASI). | After four weeks of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI). | After four weeks of treatment. |
Countries
Israel
Outcome results
None listed