Status:
COMPLETED
A Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris
Lead Sponsor:
University of Michigan
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 cha...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00113542
Start Date
June 1 2004
End Date
June 1 2005
Last Update
May 21 2015
Active Locations (1)
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1
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109