PSORIASIS MedDRA version: 12.0 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Trade Name: CRESTOR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Rosuvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Objective of this study is to demonstrate an anti-inflammatory effect of Rosuvastatin therapy in patients affected by Psoriasis in term of: 1) significant reduction in one or more systemic inflammatory markers (CRP plasma levels, IL-6, Hs-Interleukin-6 , IFN and TNF-alpha, Myeloperoxidase) or 2) significant reduction in levels of circulated CD4-CD28 null and inflammatory infiltration in the skin biopsy;Secondary Objective: The secondary Objectives are to demonstrate an higher presence of initial stigmata of atherosclerosis (IMT) in patients with more severe manifestations of skin disease compared with patients with mild form, also evaluating IMT modifications after 30 days treatment with 20 mg of Rosuvastatin/die to demonstrate an higher systemic inflammatory state in patients with moderate-severe psoriasis compared with patients with mild form.;Primary end point(s): Primary end-point is the demonstration of a significant reduction in one or more inflammatory markers (CRP, IL-6, IL-2, TNFalpha, INF gamma, MPO and of circulated CD4-CD28 null and inflammatory infiltration in the skin biopsy) after 30 days treatment with Rosuvastatin in patients with Psoriasis. | — |
Countries
Italy
Outcome results
None listed