Fluphenazine Decanoate for Psoriasis
Psoriasis
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Adults 18 to 65 years of age with psoriasis, in general good health Must have symmetric target lesions approximately 2-4 cm in diameter on each side of the body (e.g., thighs) with baseline target lesion score of 6 or higher (scale of 0-12) for each target Women of childbearing potential must agree to use two forms of contraception for the duration of the study Exclusion Criteria: Infliximab (Remicade) or alefacept (Amevive) within the past 6 months (24 weeks) Etanercept (Enbrel), efalizumab (Raptiva), adalimumab (Humira), or other tumor necrosis factor- (TNF)-alpha inhibitor within the past 3 months (12 weeks) Other systemic psoriasis therapies (e.g., methotrexate, cyclosporine, acitretin) or PUVA (psoralen plus ultraviolet A) within the past 4 weeks Ultraviolet B (UVB) or topical therapy (other than over the counter (OTC) moisturizers and shampoos) within the past 2 weeks (including topical corticosteroids, vitamin A and D analogues) Receipt of an investigational agent within the past 4 weeks Systemic corticosteroid therapy Inability to understand consent or comply with protocol Pregnancy, lactation, or unwillingness to use adequate birth control during the study Impaired hepatic function Known Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), hepatitis B/C Blood dyscrasia Epilepsy Tardive dyskinesia Excessive alcohol consumption Current use of selective serotonin reuptake inhibitors (SSRI), tricyclic, or norephinephrine reuptake inhibitor antidepressants or use within 6 weeks of beginning the study Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy Use of phenothiazine antipsychotics or anticholinergics Known allergy to fluphenazine decanoate or other phenothiazines Known allergy to parabens/para-aminobenzoic acid (PABA), benzyl alcohol, sesame oil or sesame seeds Clinically significant mitral valve disease Clinically significant and uncontrolled cardiovascular disease QTc >450 msec, or evidence of a clinically significant dysrhythmia on electrocardiography (ECG) Operator of heavy machinery Pheochromocytoma History of breast cancer History of seizure disorder Occupational exposure to organophosphate insecticides Parkinson's disease and other related movement disorders Lab abnormalities including: Alanine aminotranferease (ALT)/aspartate aminotransferase (AST) ≥ 2X upper limit of reference range Creatinine ≥ 1.5X upper limit of reference range Bilirubin ≥ 2X upper limit of reference range Absolute total lymphocyte or polymorphonuclear leucocyte count ≤ 1000/uL or ≥ 3X upper limit of ref range Platelets ≤ 80,000/uL Hemoglobin ≤ 8.0 g/dL Glucose ≥ 200 mg/dL Fasting blood sugar ≥ 126 mg/dL Concurrent use of drugs listed in Appendix F
Sites / Locations
- Tufts-New England Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fluphenazine treated
Placebo
Treated with fluphenazine
Treated with Placebo