Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.)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
Information provided by (Responsible Party):
shmuel fuchs, Rabin Medical Center

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Atorvastatin Drug: Atorvastatin
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients older than 20 years
  • Patients with psoriasis of at least 3-years duration
  • Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
  • Statin-naïve patients
  • No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)
  • LDL levels

    • LDL level > 70 mg% and < 160 mg% in low risk patients (defined as having none or a single risk factor*)
    • LDL > 70 mg% and < 130 mg% in moderate risk patients (defined as the presence of 2 or more risk factors*)
    • LDL > 70 mg% and < 100 mg% in patients with type II diabetes
  • hsCRP ≥ 1 mg/l * Risk factors: smoking, hypertension (blood pressure > 140/90 or current treatment with blood pressure lowering agents, HDL < 40 mg%, family history of premature coronary artery disease in a first degree relative younger than 45 (men) or 55 (women) and obesity (BMI ≥ 30).

Exclusion Criteria:

  • Current statin therapy
  • Patents with Atrial Fibrillation
  • Elevated liver enzymes (> X3 ULN)
  • History of statin-induced liver enzyme elevation
  • Elevated CPK levels (> X3 ULN)
  • History of myopathy including statin-induced
  • Severe chronic renal failure (GFR <30 ml/min)
  • Pregnant or breast-feeding women
  • Individuals at risk for poor protocol, or medication compliance
  • Patients with life-expectancy of less than 2 years
  • Patients who are currently participating in another clinical trial
  • Other current active inflammatory and/or infectious conditions
  • Sensitivity to any of atorvastatin ingredients
  • Concomitant drug therapy, taken on a regular basis, which may interact with Atorvastatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527097

Rabin Medical Center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
shmuel fuchs
Study Director: Shmuel Fuchs, Professor Rabin Medical Center, Israel

Responsible Party: shmuel fuchs, Prof Shmuel Fuchs, MD, MACC, FSCAI, Rabin Medical Center Identifier: NCT01527097     History of Changes
Other Study ID Numbers: 0263 - 11 - RMC
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by shmuel fuchs, Rabin Medical Center:
Cardiovascular Diseases
Pharmacologic Actions
Endothelial Function
Inflammatory Disease
Skin Disease

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors