Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Fluphenazine Hydrochloride for Psoriasis (FP-CL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929578
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : August 2, 2016
Last Update Posted : March 31, 2017
Immune Control
Information provided by (Responsible Party):
Tufts Medical Center

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Fluphenazine Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis
Study Start Date : November 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

  3. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929578

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
Additional Information:
Layout table for additonal information
Responsible Party: Tufts Medical Center Identifier: NCT00929578    
Other Study ID Numbers: FP-CL2
First Posted: June 29, 2009    Key Record Dates
Results First Posted: August 2, 2016
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tufts Medical Center:
Additional relevant MeSH terms:
Layout table for 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