Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Atorvastatin; Placebo
Intervention description: Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia; Placebo tablets, made to look like the interventional drug
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic plaque psoriasis; psoriasis; atorvastatin; psoriasis area and severity index; betamethasone valerate

Summary:

      This study aimed to assess the efficacy and safety of atorvastatin 40 mg/day as an adjunct to
      betamethasone valerate 0.1% ointment applied twice daily in the treatment of patients with
      mild to moderate chronic plaque type psoriasis, as determined by mean reduction in PASI
      scores. Specific objectives included the determination and comparison of the absolute number
      and proportion of patients who achieved PASI-50 and the mean reductions in lipid profile
      (total cholesterol, HDL, LDL, triglycerides) and high-sensitivity C-reactive protein (hsCRP)
      measured from baseline and every month thereafter up to 6 months of treatment. This study
      also investigated the impact of atorvastatin treatment on the patients' quality of life as
      well as the association of clinical response to the lipid-lowering and anti-inflammatory
      effects of atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with mild to moderate psoriasis vulgaris, chronic plaque type, with
             PASI score not more than 10

          -  Adult patients ≥ 19 years old and ≤ 65 years old

          -  Male or female

          -  Able to give consent

          -  Able to follow-up monthly for 6 months

        Exclusion Criteria:

          -  Patients with PASI score ≥ 10

          -  Systemic therapy for psoriasis within the last two months

          -  Phototherapy within the last four weeks

          -  Known allergy to any of the treatments

          -  Active liver disease or liver enzymes (AST and ALT) more than 3 times the upper limit
             of normal

          -  Any myopathy or presence of elevated creatine kinase (CK-MM) levels

          -  Intake of any drug that might affect or interact with the study drug (e.g. fibrates,
             niacin, macrolide antibiotics)

          -  Patients already taking statins or patients with clear indications for statin
             treatment (i.e. coronary heart disease or disease equivalents according to the Adult
             Treatment Panel III Guidelines)

          -  Impaired renal function or creatinine > 2.0 mg/dL

          -  Active infection or WBC > 10

          -  Pregnant or lactating

          -  Uncontrolled hypertension, endocrine or other metabolic diseases