Phase 2
N=28
Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02432040 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months — -2.15; -1.69 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Philippine Dermatological Society
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months |
-2.15; -1.69 | — |
| PRIMARY Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months |
27.3; 45.5 | — |
| SECONDARY Monthly Mean Changes in PASI Scores |
-0.72; -0.71; -1.67; -0.69; -2.19; -1.16 | — |
| SECONDARY Percentage of Patients Achieving PASI-50 at the End of 3 Months |
36.4; 18.2 | — |
| SECONDARY Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months |
-6.5; -2.13 | — |
| SECONDARY Mean Change in Lipid Profile Levels |
-35.39; -38.32; -17.55; -5.12; -45.18; -13.48 | — |
| SECONDARY Mean Change in hsCRP Levels |
-7.58; -5.14 | — |
| SECONDARY Adverse Events |
2; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02432040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.