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Fluphenazine Hydrochloride for Psoriasis (FP-CL2)

This study has been completed.
Immune Control
Information provided by (Responsible Party):
Tufts Medical Center Identifier:
First received: June 25, 2009
Last updated: March 2, 2017
Last verified: March 2017
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.

Condition Intervention Phase
Drug: Fluphenazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis

Resource links provided by NLM:

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks [ Time Frame: 4 weeks ]
    Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.

Secondary Outcome Measures:
  • Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks [ Time Frame: 4 weeks ]
    Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.

  • Safety Outcome Measures [ Time Frame: 8 weeks ]
    adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.

  • Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose. [ Time Frame: 1 week ]
    Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.

Enrollment: 15
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
Drug: Placebo
Intralesional injection of placebo
Other Name: Bacteriostatic Sodium Chloride
Active Comparator: Fluphenazine
This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
Drug: Fluphenazine
Intralesional injection of Fluphenazine
Other Name: FP-CL2

Detailed Description:

This is a double-blind, placebo-controlled, bilateral, ascending dose study.

In vitro, fluphenazine has been shown to suppress growth of proliferating T-lymphocytes. Fluphenazine would be expected to also suppress growth of proliferating T-lymphocytes in psoriatic plaques.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00929578

United States, Massachusetts
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States, 02111
United States, New Jersey
Robert Wood Johnson Medical School, Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Tufts Medical Center
Immune Control
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
  More Information

Additional Information:
Responsible Party: Tufts Medical Center Identifier: NCT00929578     History of Changes
Other Study ID Numbers: FP-CL2
Study First Received: June 25, 2009
Results First Received: August 13, 2012
Last Updated: March 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Tufts Medical Center:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Fluphenazine depot
Fluphenazine enanthate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017