Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.
The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.|
- The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes). [ Time Frame: 3,6 and 12 months after randomization. ] [ Designated as safety issue: No ]Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.
Other Name: Lipitor
|Placebo Comparator: Placebo||
Drug: Atorvastatin placebo
Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.
|Contact: Shmuel Fuchs, Professor||972 - 3 - firstname.lastname@example.org|
|Contact: Maya Arlyuk, Study Coordinatoremail@example.com|
|Rabin Medical Center, Beilinson Hospital||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Contact: Shmuel Fuchs, Professor 972-3-9376601\3 firstname.lastname@example.org|
|Contact: Maya Arlyuk, Study Coordinator email@example.com|
|Principal Investigator: Shmuel Fuchs, Professor|
|Study Director:||Shmuel Fuchs, Professor||Rabin Medical Center, Israel|