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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02432040 |
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Date of registration:
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28/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis
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Scientific title:
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Atorvastatin as Adjunctive Therapy for Chronic Plaque Type Psoriasis Versus Betamethasone Valerate Alone:A Randomized, Double-Blind, Placebo-Controlled Trial |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02432040 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Sharlene H Chua, Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of the Philippines-Philippine General Hospital Section of Dermatology |
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Name:
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Ma. Lorna F Frez, Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of the Philippines-Philippine General Hospital Section of Dermatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Atorvastatin
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Drug: Placebo
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Primary Outcome(s)
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Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months
[Time Frame: 6 months]
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Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months
[Time Frame: 6 months]
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Secondary Outcome(s)
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Mean Change in hsCRP Levels
[Time Frame: 6 months]
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Mean Change in Lipid Profile Levels
[Time Frame: 6 months]
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Monthly Mean Changes in PASI Scores
[Time Frame: Monthly from baseline to 6 months]
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Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months
[Time Frame: 6 months]
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Adverse Events
[Time Frame: 6 months]
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Percentage of Patients Achieving PASI-50 at the End of 3 Months
[Time Frame: 3 months]
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Secondary ID(s)
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PDS_PGH_2013_002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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