A Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris

NCT00113542 | Completed Phase 2

• 1 other identifier: Derm 508
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Tetrathiomolybdate

Outcome Measures

Primary Outcomes (2)

• Improvement in psoriasis as measured by PASI (psoriasis area and severity index)

• Erythema, scaling, and thickness of target lesions

Secondary Outcomes (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.

Interventions

Tetrathiomolybdate (TM) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

tetrathiomolybdate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2005
• First Posted: June 9, 2005
• Study Start: June 1, 2004
• Study Completion: June 1, 2005
• Last Updated: May 21, 2015

Record last verified: 2008-08

Locations

US (1)