moderate to severe plaque psoriasis with scalp involvement

Conditions: Psoriasis

Summary: the purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * must provide written informed consent before any study-specific procedure * be male or female greater than or equal to 18 years of age at time of screening * has stable moderate to severe plaque psoriasis for at least 6 months * affected body surface area (bsa) greater than or equal to 10% * psoriasis area and severity index (pasi) score greater than or equal to 10 * at least 30 percent affected scalp surface area * psoriasis scalp severity index (pssi) score greater than or equal to 15 * candidate for systemic therapy or phototherapy in the opinion of the investigator * negative test for hepatitis b surface antigen, hepatitis c antibody, and human immunodeficiency virus (hiv) * negative serum pregnancy test for female subjects (unless 3 years post menopausal or surgically sterile) * willing to use medically acceptable form of birth control for duration of study * negative purified protein derivative (ppd) within 30 days prior to first dose of study drug exclusion criteria: * any active infection * significant concurrent medical conditions, including: insulin dependent diabetes mellitus; congestive heart failure; myocardial infarction within last year; unstable angina pectoris; uncontrolled hypertension; severe pulmonary disease \[requiring oxygen therapy or hospitalization\]; systemic lupus erythematosus; multiple sclerosis or any other demyelinating disease; active malignancy * any condition, in opinion of study doctor, that might cause this study to be detrimental to subject * history of cancer within 5 years before first dose of study drug * skin conditions other than psoriasis that would interfere with evaluations of the effect of study medications on psoriasis * presence of guttate, erythrodermic or pustular psoriasis * use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of study drug * use of tar shampoos within 14 days of first dose of study drug * use of following therapies within 28 days of first dose of study drug: iv or oral cyclosporine or calcineurin inhibitors, ultraviolet light a therapy, psoralen plus ultraviolet a radiation, oral retinoids, ultraviolet light b therapy, topical steroids or steroid shampoo, topical vitamin a or d analog preparations, anthralin, other systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra * use of alefacept (amevive), efalizumab (raptiva), anti-tumor necrosis factor (tnf) biologic therapies within 3 months of the first dose of study drug. prior anti-tnf use will not be permitted if discontinued due to lack of efficacy, an adverse event, or non-compliance. * use of interleukin (il)-12/il-23 within 6 months of the first dose of study drug * participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) of randomization * laboratory abnormalities at screening: hemoglobin less than 11 g/dl, platelet count less than 125,000/mm\^3, white blood cell count less than 3,500 cells/mm\^3, aspartate aminotransferase (ast)/alanine aminotransferase (alt) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results * patient is pregnant or breast feeding * presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition

Keywords: scalp psoriasis plaque psoriasis skin diseases moderate to severe plaque psoriasis etanercept