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

December 31, 2015 updated by: Dr. Sunil Dogra, Postgraduate Institute of Medical Education and Research

Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis: A Prospective Randomized Double Blind Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Topical Coal tar
Topical coal tar to be applied once daily
Drug: Topical calcipotriol
Topical calcipotriol to be applied once daily
Drug: Placebo
Placebo drug twice daily given in the intervention arm to patients of moderate psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Sunil Dogra, MD, Postgraduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/1842/Res/1096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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