Status:
TERMINATED
Fluphenazine Decanoate for Psoriasis
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Immune Control
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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. Fo...
Detailed Description
Psoriasis is a hyperproliferative, inflammatory, immune-mediated skin disease that affects approximately 2% of the United States and European populations (Tutrone 2001, Kipnis 2005). This disease mani...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00356200
Start Date
July 1 2006
End Date
September 1 2008
Last Update
December 22 2010
Active Locations (1)
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1
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111