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Trial record 15 of 1714 for:    psoriasis

Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis

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ClinicalTrials.gov Identifier: NCT02644954
Recruitment Status : Unknown
Verified December 2015 by Dr. Sunil Dogra, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Sunil Dogra, Postgraduate Institute of Medical Education and Research

Brief Summary:

Psoriasis vulgaris is a common, chronic, relapsing skin disease characterized by predominant involvement of skin, nails and joints. Recent advances in its patho-physiology have shifted the notion of psoriasis from that of a 'disease of the skin' to a 'T-cell mediated systemic disease'. Better understanding of its pathogenesis and co-morbidities along with the development of novel therapeutics like biological response modifiers has changed the way dermatologists approach the management of psoriasis. Based on the extent of involvement and effect on the quality of life, psoriasis may be mild to moderate in severity. This in turn forms the basis of treatment in majority of the patients. Topical therapies like coal tar, calcipotriol and corticosteroids are sufficient for mild and localized psoriasis. In more widespread or severe forms that are associated with significant decrease in quality of life of patient, phototherapy and systemic therapies are indicated either alone or in combination with each other. Although the introduction of biological therapies has revolutionized the treatment of psoriasis in recent years, such newer therapeutic options continue to elude the vast majority of patients in the developing and under developed world where the traditional agents like methotrexate, cyclosporine, acitretin and phototherapy still form the backbone of treatment.

The association of psoriasis with metabolic syndrome is now well documented. Metabolic syndrome is a cluster of risk factors including central obesity, atherogenic dyslipidemia, hypertension and glucose intolerance and is a strong predictor of cardiovascular diseases, diabetes and stroke. Metformin, an oral hypoglycemic agent of biguanide class is known for its multitude of action on various facets of metabolic syndrome. Recently it has also been found to inhibit keratinocyte proliferation in cell culture model of psoriasis.

The present study is designed as a randomized controlled double blind pilot study in which 40 patients with chronic plaque psoriasis of moderate severity (PASI ≥ 6 or DLQI ≥ 6) and metabolic syndrome (By modified ATP III criteria)4 or impaired glucose tolerance (defined as two-hour glucose levels of 140 to 199 mg per dL on the 75-g oral glucose tolerance test) will be recruited and randomized into two arms, A and B of 20 each, by using random number tables. Patients in arm A will be treated with topical anti-psoriatic treatment (including coal tar and vitamin D3 analogues only) and oral metformin 1g/day 850mg twice daily and patients in arm B will be treated with topical anti-psoriatic treatment and oral placebo tablets. Post randomization patients will be followed up at regular intervals for 24 weeks. During each visit, patients in both arms will be assessed for the severity of psoriasis by psoriasis activity severity index (PASI) and body mass index (BMI). Fasting blood glucose and insulin level, glycosylated haemoglobin (HbA1c) and parameters of metabolic syndrome (including waist circumference, fasting lipid profile and blood pressure) will be assessed at baseline and again at week 16 and 24. The primary aim of this study is to assess the efficacy and safety of oral metformin as an add on therapy for the treatment of chronic plaque psoriasis of moderate severity. The secondary aim is to assess the effect of metformin on parameters of the metabolic syndrome.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Metformin Drug: Placebo Drug: Topical Coal tar Drug: Topical calcipotriol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis: A Prospective Randomized Double Blind Controlled Study
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Metformin
Topical coal tar and topical calcipotriol + oral metformin 850mg twice daily
Drug: Metformin
Metformin 850 mg twice daily given in the intervention arm to patients of moderate psoriasis

Drug: Topical Coal tar
Topical coal tar to be applied once daily

Drug: Topical calcipotriol
Topical calcipotriol to be applied once daily

Placebo Comparator: Placebo
Topical coal tar and topical calcipotriol
Drug: Placebo
Placebo drug twice daily given in the intervention arm to patients of moderate psoriasis

Drug: Topical Coal tar
Topical coal tar to be applied once daily

Drug: Topical calcipotriol
Topical calcipotriol to be applied once daily




Primary Outcome Measures :
  1. The proportion of patients achieving 75% reduction in psoriasis activity severity index (PASI) [ Time Frame: 1 year ]
    Evaluate the efficacy of oral metformin in chronic plaque psoriasis of moderate severity. The proportion of patients achieving PASI 75 assesses the efficacy.


Secondary Outcome Measures :
  1. The proportion of patients achieving 90% reduction in psoriasis activity severity index (PASI) [ Time Frame: 1 year ]
  2. The number of patients who show change in parameters of metabolic syndrome after taking metformin [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic plaque psoriasis of moderate severity, defined as PASI ≥ 6 and/or DLQI ≥ 6
  • Metabolic syndrome (By modified ATP III criteria)4 or impaired glucose tolerance (defined as two-hour glucose levels of 140 to 199 mg per dL on the 75-g oral glucose tolerance test.)

Exclusion Criteria:

  • Known drug allergies to biguanides.
  • Psoriatic arthritis
  • Pustular psoriasis
  • Severe psoriasis PASI>10, DLQI> 10
  • Patient with overt diabetes mellitus, defined as fasting blood sugar > 126mg/dl glucose tolerance test of >200mg/dl.
  • Intake of oral hypoglycemic or systemic anti-psoriatic medication within the last 4 weeks.
  • Patients on medications for cardiovascular, gastrointestinal, hepatic, renal, disorders

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): NCT02644954


Contacts
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Contact: Sunil Dogra, MD sundogra@hotmail.com
Contact: Tarun Narang, MD narangtarun@yahoo.co.in

Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Sunil Dogra, MD Postgraduate Institute of Medical Education and Research

Publications:

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Responsible Party: Dr. Sunil Dogra, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02644954     History of Changes
Other Study ID Numbers: NK/1842/Res/1096
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by Dr. Sunil Dogra, Postgraduate Institute of Medical Education and Research:
psoriasis
Metformin
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Metformin
Calcipotriene
Coal Tar
Hypoglycemic Agents
Physiological Effects of Drugs
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents
Keratolytic Agents