- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929578
Fluphenazine Hydrochloride for Psoriasis (FP-CL2)
Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center, Department of Dermatology
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Robert Wood Johnson Medical School, Psoriasis Center of Excellence
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
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Intralesional injection of placebo
Other Names:
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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.
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Intralesional injection of Fluphenazine
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks
Time Frame: 4 weeks
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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.
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4 weeks
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Safety Outcome Measures
Time Frame: 8 weeks
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adverse events will be recorded and monitored.
Adverse events will be noted in a separate chart.
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8 weeks
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Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.
Time Frame: 1 week
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Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.
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1 week
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Fluphenazine
- Fluphenazine depot
- Fluphenazine enanthate
Other Study ID Numbers
- FP-CL2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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