Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

NCT02432040 | Completed Phase 2 Results DMC

• 1 other identifier: PDS_PGH_2013_002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

chronic plaque psoriasis; psoriasis; atorvastatin; psoriasis area and severity index; betamethasone valerate

Outcome Measures

Primary Outcomes (2)

• Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months

  Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.

  6 months

• Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months

  Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared

  6 months

Secondary Outcomes (6)

• Monthly Mean Changes in PASI Scores

  Monthly from baseline to 6 months

• Percentage of Patients Achieving PASI-50 at the End of 3 Months

  3 months

• Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months

  6 months

• Mean Change in Lipid Profile Levels

  6 months

• Mean Change in hsCRP Levels

  6 months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

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

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Atorvastatin DRUG

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

Also known as: Atopitar

Atorvastatin

Placebo DRUG

Placebo tablets, made to look like the interventional drug

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philippine Dermatological Society: lead

Study Sites (1)

University of the Philippines - Philippine General Hospital Section of Dermatology

Manila, Manila, 1000, Philippines

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Sharlene Chua
• Organization: University of the Philippines - Philippine General Hospital Section of Dermatology

sharlene_chua@yahoo.com

2418118

Study Officials

• Sharlene H Chua, Medicine

  University of the Philippines-Philippine General Hospital Section of Dermatology

  PRINCIPAL INVESTIGATOR

• Ma. Lorna F Frez, Medicine

  University of the Philippines-Philippine General Hospital Section of Dermatology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-10

Locations

PH (1)