Fluphenazine Decanoate for Psoriasis

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: Immune Control
• Treatments: Decanoic acid; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate

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