Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
|ClinicalTrials.gov Identifier: NCT01527097|
Recruitment Status : Withdrawn (We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.)
First Posted : February 6, 2012
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Atorvastatin Drug: Atorvastatin placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||August 2012|
|Primary Completion Date :||April 2015|
|Study Completion Date :||April 2015|
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.
- 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. ]Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527097
|Rabin Medical Center, Beilinson Hospital|
|Petach Tikva, Israel, 49100|
|Study Director:||Shmuel Fuchs, Professor||Rabin Medical Center, Israel|