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Fluphenazine Hydrochloride for Psoriasis (FP-CL2)

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ClinicalTrials.gov Identifier: NCT00929578
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : August 2, 2016
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Immune Control
Information provided by (Responsible Party):
Tufts Medical Center

Tracking Information
First Submitted Date  ICMJE June 25, 2009
First Posted Date  ICMJE June 29, 2009
Results First Submitted Date  ICMJE August 13, 2012
Results First Posted Date  ICMJE August 2, 2016
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
The following primary biologic activity outcome measure will be evaluated at 4 weeks: Improvement in target lesion scoring. [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT00929578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
  • The following secondary biologic activity outcome measure will be evaluated at 4 weeks: Improvement from baseline in the target lesion Visual Analog Scale (VAS) score for pruritus. [ Time Frame: 4 weeks ]
  • Safety Outcome Measures: All adverse events will be recorded and monitored. [ Time Frame: 8 weeks ]
  • Fluphenazine serum levels to be measured at baseline, after 2 hours & after 1 week. [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluphenazine Hydrochloride for Psoriasis
Official Title  ICMJE Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Fluphenazine
    Intralesional injection of Fluphenazine
    Other Name: FP-CL2
  • Drug: Placebo
    Intralesional injection of placebo
    Other Name: Bacteriostatic Sodium Chloride
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Fluphenazine
Publications * Gupta MA, Guptat AK. The use of antidepressant drugs in dermatology. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):512-8. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929578
Other Study ID Numbers  ICMJE FP-CL2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Immune Control
Investigators  ICMJE
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
PRS Account Tufts Medical Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP