Fluphenazine Hydrochloride for Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Fluphenazine; Placebo
Intervention description: Intralesional injection of Fluphenazine; Intralesional injection of placebo
Intervention MeSH terms: Fluphenazine; Fluphenazine depot; Fluphenazine enanthate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriasis; T-lymphocytes; Fluphenazine

Summary:

      The objective of this study is to assess the safety and biologic activity of intralesional
      injection of fluphenazine in adult subjects with psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 to 65 years of age with psoriasis, in general good health as determined by
             the Principal Investigator based upon the results of medical history, laboratory
             profile, and physical examination

          -  Must have symmetric target lesions 2-4 cm in diameter on each side of the body (e.g.,
             thighs) with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12) for
             each target

          -  Women are eligible to participate in the study if they meet one of the following
             criteria:

               -  Women who are postmenopausal (for at least one year), sterile, or hysterectomized

               -  Women of childbearing potential must undergo monthly pregnancy testing during the
                  study and agree to use two of the following methods of contraception throughout
                  the study and for 60 days after the last dose of study drug:

                    -  Oral contraceptives

                    -  Transdermal contraceptives

                    -  Injectable or implantable methods

                    -  Intrauterine devices

                    -  Barrier methods (diaphragm with spermicide, condom with spermicide)

        (Abstinence and Tubal Ligation are also considered a form of Birth control.)

        Exclusion Criteria:

          -  Patient is not asymptomatic and has major ailments on screening exam.

          -  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
             oral psoralen with ultraviolet A (PUVA) 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) with the exception of betamethasone valerate lotion (0.01%) for
             treatment of scalp lesions, and triamcinolone cream (0.1%) for lesions at least 3
             inches away from the target lesions

          -  Receipt of an investigation agent within the past 4 weeks

          -  Systemic corticosteroid therapy

          -  Inability to understand consent or comply with protocol (patients will be asked if
             they understand or have any questions)

          -  Pregnancy, lactation, or unwillingness to use adequate birth control during the study

          -  Impaired hepatic function

          -  Known HIV/AIDS, hepatitis B/C

          -  Blood dyscrasia

          -  Epilepsy

          -  Tardive dyskinesia

          -  Excessive alcohol consumption (drinking more than two drinks per day on average for
             men or more than one drink per day on average for women)

          -  Use of phenothiazine antipsychotics or anticholinergics

          -  Current use of selective serotonin reuptake inhibitor (SSRI), tricyclic, or
             norepinephrine 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

          -  Known allergy to fluphenazine or other phenothiazines, sesame oil or sesame seeds

          -  Known allergy to parabens, para-aminobenzoate (PABA) or benzyl alcohol

          -  Clinically significant and uncontrolled cardiovascular disease

          -  corrected QT interval (QTc) > 450 msec, or evidence of a clinically significant
             dysrhythmia on ECG

          -  Operator of heavy machinery

          -  Pheochromocytoma

          -  Clinically significant mitral valve disease

          -  History of breast cancer

          -  History of seizure disorder

          -  Occupational exposure to organophosphate insecticides

          -  Parkinson's disease and other related movement disorders

          -  Screening Lab abnormalities including:

               -  Serum Asparate transaminase (AST) or Alanine transaminase (ALT) > 2.5 upper
                  limits of normal

               -  Creatinine ≥ 1.6 mg/dL

               -  Bilirubin ≥ 1.5 mg/dL

               -  White blood cell (WBC) count < 3 x 10^9 /L

               -  Platelets < 100 x 10^9/L

               -  Hemoglobin < 10 g/dL in females or < 12g/dL in males

               -  Glucose ≥ 200 mg/dL

               -  Fasting blood sugar ≥ 126 mg/dL

          -  Concurrent use of drugs listed in Appendix E of protocol