Fluphenazine Decanoate for Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Fluphenazine Decanoate; Placebo
Intervention description: Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: "APP Pharmaceuticals" is the name of the pharmaceutical company; APP is not an acronym.; The sterile placebo (sesame oil with 1.2% (w/v) benzyl alcohol) was prepared at the University of Iowa, Division of Pharmaceutical Services, a FDA registered pharmaceutical manufacturing facility.
Intervention MeSH terms: Fluphenazine; Fluphenazine depot; Fluphenazine enanthate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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