Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

NCT ID: NCT02432040

Last Updated: 2015-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-11-30

Brief 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.

Detailed Description

This was a single-center, parallel-group, randomized, double-blind, placebo-controlled clinical trial. The study was conducted from February 2013 to October 2013 at a dermatology out-patient clinic in a tertiary hospital in the Philippines. Twenty-eight patients aged 19-65 years old assessed to have mild to moderate chronic plaque psoriasis, with psoriasis area and severity index (PASI) scores less than 10, were enrolled into the study and randomized into two equal treatment groups. Before participating in the study, patients were required to have a washout period of psoriasis pharmacotherapy for at least 2 months for phototherapy and systemic drugs, and 2 weeks for topical therapies.

Exclusion criteria were as follows: patients with uncontrolled hypertension, endocrine or other metabolic diseases; patients with known allergy to any of the treatments; patients with active liver disease or liver enzymes (AST and ALT) thrice the upper limit; patients with any myopathy or presence of elevated creatine kinase (CK-MM) levels; patients taking any drug that might interact with statins and those already taking statins or patients with clear indications for statin treatment; patients with impaired renal function or creatinine > 2.0 mg/dL; patients with active infection or white blood cell (WBC) > 10 and pregnant or lactating females. The study was conducted in accordance with the Declaration of Helsinki and approved by the ethics committee. Informed consent was obtained from all participants at study entry.

Patients were randomly assigned into the two groups through a computer-generated randomization table with sequencing of assignments unknown to the primary investigator. The assigned interventions were placed in sequentially-numbered, opaque envelopes, which were opened by one of the secondary investigators only after the patient had agreed to participate in the study. Patients were assigned numerical codes that were indicated in their case record forms.

Fourteen patients took atorvastatin 40 mg once a day while 14 patients took a similar-looking placebo tablet once a day. The study duration was 6 months. All patients were allowed to continue the use of betamethasone valerate 0.1% ointment twice a day for the duration of the study. Dispensing of the medications was done by a secondary investigator, while clinical assessment was done by the primary investigator who was blinded to the treatment assignments.

Patients' PASI scores, lipid profiles, aspartate aminotransferase (AST), alanine aminotransferase (ALT), hsCRP levels, and dermatology life and quality index (DLQI) scores were taken at baseline. Recording of the lipid profile, and AST, ALT values was done by another secondary investigator so that the primary investigator would not be biased by the decreasing values of the lipid profile or elevations in the AST or ALT. Photo-documentation was done throughout the study. Patients were also asked to bring their medications each visit so that the primary investigator could check for compliance. PASI scores, lipid profiles, AST, and ALT levels were monitored monthly, while DLQI scores and hsCRP levels were evaluated again after 6 months of therapy. Difference in the mean changes in PASI scores, lipid profile levels, DLQI scores, and hsCRP levels between groups were compared. Difference in the proportion of patients reaching 50% reduction in PASI scores (PASI-50) after 3 months and that after 6 months of therapy were compared. Correlation between the changes in PASI scores and the changes in lipid profile levels, as well as correlation between the changes in PASI scores and the changes in hsCRP levels were computed.

The period of observation for adverse events started from the time the subject received the first dose of the study drug until his last follow-up. Adverse event monitoring was by active query and spontaneous reporting.

Intention-to-treat analysis was the primary efficacy analysis. Patients included were those who had at least one assessment beyond baseline (Month 1). The last measurement of each randomized patient was moved forward to represent the end-of-treatment measurement at 6 months. Per-protocol analysis was the secondary efficacy analysis. All data analyses were performed using a statistical software (STATA 12.0).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Atorvastatin

Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia

Placebo

Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets, made to look like the interventional drug

Interventions

Atorvastatin

Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia

Intervention Type: DRUG

Placebo

Placebo tablets, made to look like the interventional drug

Intervention Type: DRUG

Other Intervention Names

Atopitar

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philippine Dermatological Society

NETWORK

Sponsor Role: lead

Responsible Party

Sharlene Chua

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharlene H Chua, Medicine

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines-Philippine General Hospital Section of Dermatology

Ma. Lorna F Frez, Medicine

Role: STUDY_DIRECTOR

University of the Philippines-Philippine General Hospital Section of Dermatology

Locations

University of the Philippines - Philippine General Hospital Section of Dermatology

Manila, Manila, Philippines

Countries

Philippines

Other Identifiers

PDS_PGH_2013_002

Identifier Type: -

Identifier Source: org_study_id