PSORIASIS AND CARDIOVASCULAR DISEASE: IMMUNOMODULATOR ROLE OF THE TREATMENT WITH ROSUVASTATIN IN PATIENTS WITH PSORIASIS OF MILD OR OF MODERATE-SEVERE SKIN DISEASE. - ND

• Conditions: PSORIASIS; MedDRA version: 12.0Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2009-014364-18-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The following inclusion criteria will have to be met:
1.age >18 years
2.active but clinically stable plaque psoriasis
3.involvement of at least 10 percent of the body surface area for the moderate-severe group and < 10% for the group with mild psoriasi
4.minimal psoriasis area-and-severity index of <10 or >10 for the two groups respectively during the screening period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following criteria will preclude participation to the study:
1.pregnancy and nursing
2.guttate, erythrodernic, or pustular psoriasis at the time of screening
3.previous treatment with etanercept or anti-TNF antibodies
4.previous treatment with anti-CD4 antibodies or interleukin-2-diphtheria-toxin fusion protein within the previous six months
5.previous treatment with biologic or investigational drug, psoralen-ultaviolet A phototherapy, systemic corticosteroids, or systemic psoriasis therapy within the previous four weeks
6.previous treatment with ultraviolet B phototherapy, topical corticosteroids, vitamin A or D analogues, or anthralin within the previous two weeks antibiotic treatment within the previous week
7.other inflammatory, tumoral, systemic or skin disease
8.recent vaccination
9.previous or current use of lipid-lowering therapy
10. current use of post menopausal hormone replacement therapy
11.evidence of hepatic disfunction (alanine amino transferase levels> twice the upper limits of the normal range)
12.a CK level more than three times the upper limits of the normal range
13.a Creatinine level higher than 2 mg/dl
14. a recent history of alcohol or drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified