A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks

Exclusion Criteria

• •Spontaneously improving or rapidly deteriorating plaque psoriasis.
• •Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk.
• •Pustular, erythrodermic or other non-plaque forms pf psoriasis.
• •Guttate psoriasis as the dominant form of psoriasis.
• •Other concomitant, serious illness or medical condition (eg., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put the patient at risk during the study.
• •History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient's participation in the trial.
• •Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (eg., alefacept) within 24 weeks of the baseline visit.
• •Systemic immunomodulatory therapy known to affect psoriasis and that does not typically decrease immune cell populations (eg., etanercept) within 12 weeks prior to the baseline visit.
• •Any phototherapy (including laser for the treatment of psoriasis), photo-chemotherapy,or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to the baseline visit.
• •Prolonged exposure to artificial or natural sources of ultraviolet radiation within 4 weeks prior to the baseline visit or intention to have such exposure during the study, thought by the investigator likely to modify the patient's psoriasis.
• •Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit.
• •Alcohol abuse during the last 2 years as defined by the consumption of \>14 standard drinks of alcohol per week.
• •Use of lithium within 2 weeks prior to the screening visit.
• •Use of beta blockers (eg., propranolol) within 2 weeks prior to the screening visit unless on a stable dose for \>3 months.
• •Known or suspected hypersensitivity to any of the constituents of the investigational product.
• •Treatment with an investigational drug within 1 month of Day 0 or current participation in another clinical trial.