Advertisement

Topics

Fluphenazine Decanoate for Psoriasis

2014-08-27 03:43:21 | BioPortfolio

Summary

We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

Description

Psoriasis is a hyperproliferative, inflammatory, immune-mediated skin disease that affects approximately 2% of the United States and European populations (Tutrone 2001, Kipnis 2005). This disease manifests as red, scaly plaques that are itchy and/or painful. Patients with psoriasis may be socially stigmatized because of their appearance. Currently, there is no cure for this condition. Often, repeated medical treatments are necessary and can become expensive. Treatment with topical corticosteroids is the mainstay therapy for mild to moderate psoriasis. In more severe cases, systemic therapies (e.g., cyclosporine) and phototherapy (e.g., ultraviolet B (UVB) irradiation) are used. These treatments, however, are associated with toxicities or inconvenience. There is anecdotal evidence to suggest that antipsychotic drugs have a beneficial effect on psoriasis (Gupta 2001, 2003).

Fluphenazine is a phenothiazine antipsychotic drug. In vitro, fluphenazine kills activated human T cells under conditions that do not affect resting T cells (Immune Control Inc. data not shown). To determine the size of a therapeutic window for human peripheral blood mononuclear cells (PBMC)s, Immune Control Inc. performed the following experiments. First, phytohemagglutinin- (PHA)-activated cells were exposed to 2, 10, or 20 µM fluphenazine for 0, 18, 24, 36, 48, or 72 hours. Second, resting cells were exposed to identical fluphenazine concentrations for identical time periods, after which the drug was washed out of the cells, and the cells activated with PHA. In all cases, deoxyribonucleic acid (DNA) synthesis was measured by exposing the cells to tritiated thymidine, and measuring the incorporated nucleotide by scintillation counting. The data show that exposure of activated cells to 10 µM fluphenazine for 72 hours, or 20 µM fluphenazine for 36 hours, caused the death of virtually all of the activated cells. The ability of the resting cells to initiate DNA synthesis after activation, by contrast, was largely unaffected by these fluphenazine exposures. Although we cannot precisely control intralesional fluphenazine concentrations, we expect that injections of up to 1 mg fluphenazine decanoate will yield local concentrations that exceed 10 µM without significant systemic fluphenazine concentrations.

We propose that fluphenazine will suppress proliferating T-lymphocytes in psoriatic plaques in vivo and thus result in healing of plaques. The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine decanoate in adult subjects with psoriasis.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Psoriasis

Intervention

Fluphenazine Decanoate, Placebo

Location

Tufts-New England Medical Center
Boston
Massachusetts
United States
02111

Status

Terminated

Source

Tufts Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:21-0400

Clinical Trials [615 Associated Clinical Trials listed on BioPortfolio]

CATIE- Schizophrenia Trial

The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-t...

Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURP...

Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.

A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting ha...

New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia

The purpose of this study is to: 1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day) and risperidone (3-4mg/day) compared to each other and to...

PubMed Articles [1247 Associated PubMed Articles listed on BioPortfolio]

Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis.

Genital psoriasis (GenPs) is a common, debilitating, and difficult to treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist.

Treatment of Genital Psoriasis: A Systematic Review.

Genital psoriasis affects approximately 63% of psoriasis patients at least once in their lifetime. More than any other area on the body, genital lesions significantly impair patients' psychologic well...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results Through 48 Weeks of a Phase 3, Multicenter, Randomized, Double-Blinded, Etanercept- and Placebo-Controlled Study (CIMPACT).

Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.

Self-care for older people with psoriasis.

Psoriasis affects 1.5% of the UK population and due to the ageing population it is more common in older people. The incidence of type II psoriasis peaks in patients between 57 and 62 years of age, and...

What is psoriasis? - Perception and assessment of psoriasis among the German population.

Delivery of health care to psoriasis patients plays an important role in the field of dermatology. Following the 2014 WHO resolution and the 2016 WHO global report, there has been an increase in the a...

Medical and Biotech [MESH] Definitions

A phenothiazine used in the treatment of PSYCHOSES. Its properties and uses are generally similar to those of CHLORPROMAZINE.

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

More From BioPortfolio on "Fluphenazine Decanoate for Psoriasis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzumab (Itolizumab)
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...


Searches Linking to this Trial