Fluphenazine Hydrochloride for Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Psoriasis
In brief
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.
Key facts
- Study ID
- NCT00929578
- Run by
- Tufts Medical Center
- People needed
- 15
- Starts
- 2008-11-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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
Where it is running
- Tufts Medical Center, Department of Dermatology — Boston, Massachusetts, United States
- Robert Wood Johnson Medical School, Psoriasis Center of Excellence — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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