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A Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113542
Recruitment Status : Completed
First Posted : June 9, 2005
Last Update Posted : May 21, 2015
Information provided by:
University of Michigan

Brief Summary:
Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a chronic, recurrent condition for which there is no cure, but there are ways to control it. Psoriasis is characterized by epidermal hyperplasia (abnormal increase in the number of normal cells of the outer layer of the skin). Tetrathiomolybdate (TM), a copper chelator (a drug that removes copper from the bloodstream) was first created to treat Wilson's disease, a disorder caused by too much copper in the blood. Studies in animals have since shown that TM may also prevent the formation of new blood vessels and may also block the key components of inflammation (swelling, redness, and pain) caused by psoriasis. TM is not approved by the FDA for any use yet. It is an investigational drug used for clinical research. We propose to test whether a new treatment with TM can in fact improve or stabilize psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Tetrathiomolybdate (TM) Phase 2

Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of Tetrathiomolybdate in psoriasis therapy. Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a chronic, recurrent condition for which there is no cure but ways to control it. Psoriasis is characterized by epidermal hyperplasia, increased dermal angiogenesis, and infiltration of activated lymphocytes. Beginning with the observation that cyclosporin A, whose primary action is to inhibit lymphokine release and proliferation of T cells, was effective in the treatment of psoriasis, the last two decades saw a major paradigm shift in the pathogenesis of psoriasis, from a view of psoriasis as a disease of epidermal origin to a view of it as an epidermal response to immunological injury. In fully activated T cells in psoriatic skin, the T1/T2 cytokine balance is shifted in favor of T1 expression, with production of IL-2 and IFN-γ. Activated T1 lymphocytes also produce TNF-α. This is a pivotal cytokine that regulates an array of proinflammatory mediators. Recently, anti-TNF-α therapy using a chimeric anti-TNF-α monoclonal antibody (infliximab) and a TNF-receptor-immunoglobulin fusion protein (etanercept) have shown to be highly effective in patients with severe psoriasis. Efforts to treat psoriasis by inhibiting neovascularization of psoriatic plaques have also been shown to be effective. A randomized phase I/II clinical trial using Neovastat, a naturally occurring inhibitor of angiogenesis, resulted in dose-dependent improvement in the Psoriasis Area and Severity Index (PASI) score, thus providing further evidence that altered angiogenesis is an integral part of psoriasis pathophysiology. Since TM has proven antiangiogenic and anti-TNF-α activities, we are very encouraged that TM therapy will be beneficial in psoriasis.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris
Study Start Date : June 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Primary Outcome Measures :
  1. Improvement in psoriasis as measured by PASI (psoriasis area and severity index)
  2. Erythema, scaling, and thickness of target lesions

Secondary Outcome Measures :
  1. Cytokine and laboratory values will be compared to baseline to test the hypothesis that TM will affect the level of TNF alpha, IL-1, C-protein, and TGF.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 + years of age
  • Psoriasis vulgaris involving greater than 5% total body surface area
  • No disease states or physical conditions which would impair evaluation of the test sites
  • Willing and able to take test medications as directed in the protocol, make evaluation visits and follow protocol restrictions
  • Failed systemic therapy for psoriasis (e.g., PUVA, retinoids, systemic steroids, methotrexate, etc.)
  • Signed, written, witnessed informed consent form
  • You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

  • Use of any topical psoriasis treatment within weeks prior to the start of the study
  • Use of any systemic medication within 4 weeks prior to the start of the study
  • Involvement in an investigational study within the previous 4 weeks
  • Inability to give informed consent
  • History of drug dependency or alcoholism
  • Severe infection within 4 weeks prior to study entry or the presence of chronic infection
  • Significant psychiatric disorder
  • Screening laboratory values which exceed the following limits:

    • Hematology - WBC <3,500 cells/mm3, Hb <10.5g/dl, platelets <100,000 cells/mm3;
    • Renal function test - creatinine >1.5 mg/dl;
    • Liver function tests - AST, alkaline phosphatase or total bilirubin more than twice the upper limits of normal, and a prothrombin time above the normal range.
  • Pregnancy or breast feeding a baby. Sexually active women of reproductive age must use an acceptable form of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113542

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United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Study Chair: John J Voorhees, MD University of Michigan

Layout table for additonal information Identifier: NCT00113542    
Other Study ID Numbers: Derm 508
First Posted: June 9, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: August 2008
Keywords provided by University of Michigan:
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents