Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113542
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-06-08
Brief Title:
A Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
An Open Label Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Psoriasis is a common skin disease affecting an estimated 26 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 Wilsons 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
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 26 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 T1T2 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 III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None