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Trial record 83 of 272 for:    Betamethasone

Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

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ClinicalTrials.gov Identifier: NCT02432040
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sharlene Chua, Philippine Dermatological Society

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Atorvastatin Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atorvastatin as Adjunctive Therapy for Chronic Plaque Type Psoriasis Versus Betamethasone Valerate Alone:A Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 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
Drug: Atorvastatin
Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia
Other Name: Atopitar

Placebo Comparator: 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
Drug: Placebo
Placebo tablets, made to look like the interventional drug




Primary Outcome Measures :
  1. Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months [ Time Frame: 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.

  2. Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months [ Time Frame: 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


Secondary Outcome Measures :
  1. Monthly Mean Changes in PASI Scores [ Time Frame: Monthly from baseline to 6 months ]
    PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.

  2. Percentage of Patients Achieving PASI-50 at the End of 3 Months [ Time Frame: 3 months ]
    PASI-50 means at least a 50% reduction from baseline PASI score

  3. Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months [ Time Frame: 6 months ]
  4. Mean Change in Lipid Profile Levels [ Time Frame: 6 months ]
  5. Mean Change in hsCRP Levels [ Time Frame: 6 months ]
  6. Adverse Events [ Time Frame: 6 months ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432040


Locations
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Philippines
University of the Philippines - Philippine General Hospital Section of Dermatology
Manila, Philippines, 1000
Sponsors and Collaborators
Philippine Dermatological Society
Investigators
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Principal Investigator: Sharlene H Chua, Medicine University of the Philippines-Philippine General Hospital Section of Dermatology
Study Director: Ma. Lorna F Frez, Medicine University of the Philippines-Philippine General Hospital Section of Dermatology

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Responsible Party: Sharlene Chua, Dr., Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT02432040     History of Changes
Other Study ID Numbers: PDS_PGH_2013_002
First Posted: May 1, 2015    Key Record Dates
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015
Last Verified: October 2015
Keywords provided by Sharlene Chua, Philippine Dermatological Society:
chronic plaque psoriasis
psoriasis
atorvastatin
psoriasis area and severity index
betamethasone valerate
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents