Fluphenazine Hydrochloride for Psoriasis (FP-CL2)

This study has been completed.
Sponsor:
Collaborator:
Immune Control
Information provided by (Responsible Party):
Alice Gottlieb, Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00929578
First received: June 25, 2009
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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
Psoriasis
Drug: Fluphenazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • The following primary biologic activity outcome measure will be evaluated at 4 weeks: Improvement in target lesion scoring. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety Outcome Measures: All adverse events will be recorded and monitored. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Fluphenazine serum levels to be measured at baseline, after 2 hours & after 1 week. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 TNF-alpha inhibitor within the past 3 months (12 weeks)
  • Other systemic psoriasis therapies (e.g., methotrexate, cyclosporine, acitretin) or PUVA within the past 4 weeks
  • UVB or topical therapy (other than 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 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, PABA or benzyl alcohol
  • Clinically significant and uncontrolled cardiovascular disease
  • 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 ClinicalTrials.gov identifier: NCT00929578

Locations
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
Investigators
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
  More Information

Additional Information:
Publications:
Responsible Party: Alice Gottlieb, Principal Investigator, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00929578     History of Changes
Other Study ID Numbers: FP-CL2
Study First Received: June 25, 2009
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tufts Medical Center:
Psoriasis
T-lymphocytes
Fluphenazine

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014