Fluphenazine Hydrochloride for Psoriasis

Condition(s) targeted: Psoriasis

Intervention: Fluphenazine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Tufts Medical Center

Official(s) and/or principal investigator(s):
Alice B. Gottlieb, M.D., PhD., Principal Investigator, Affiliation: Tufts Medical Center, Department of Dermatology

Overall contact:
Nicole Dumont, Phone: 617-636-7462, Email: ndonovan1@tuftsmedicalcenter.org

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

Official title: Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The following primary biologic activity outcome measure will be evaluated at 4 weeks: Improvement in target lesion scoring.

Secondary outcome:

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.

Safety Outcome Measures: All adverse events will be recorded and monitored.

Fluphenazine serum levels to be measured at baseline, after 2 hours & after 1 week.

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Nicole Dumont, Phone: 617-636-7462, Email: ndonovan1@tuftsmedicalcenter.org

Tufts Medical Center, Department of Dermatology, Boston, Massachusetts 02111, United States; Recruiting
Nicole Dumont, Phone: 617-636-7462, Email: ndonovan1@tuftsmedicalcenter.org
Alice B. Gottlieb, M.D., PhD, Principal Investigator

Robert Wood Johnson Medical School, Psoriasis Center of Excellence, New Brunswick, New Jersey 08903, United States; Recruiting
Claudia Van Saders, R.N., Phone: 732-235-5741, Email: vansadcl@umdnj.edu
Melissa Magliocco, M.D., Sub-Investigator

Tufts Medical Center, Department of Dermatology, Research

Related publications:

Gupta MA, Guptat AK. The use of antidepressant drugs in dermatology. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):512-8. Review.

Starting date: November 2008
Last updated: February 1, 2010