Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philippine Dermatological Society
• Treatments: Atorvastatin; Atorvastatin Calcium; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

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