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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

Tracking Information
First Submitted Date  ICMJE December 22, 2015
First Posted Date  ICMJE January 1, 2016
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
  • The proportion of patients achieving 90% reduction in psoriasis activity severity index (PASI) [ Time Frame: 1 year ]
  • The number of patients who show change in parameters of metabolic syndrome after taking metformin [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis
Official Title  ICMJE Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis: A Prospective Randomized Double Blind Controlled Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Metformin
    Metformin 850 mg twice daily given in the intervention arm to patients of moderate psoriasis
  • 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
Study Arms  ICMJE
  • Active Comparator: Metformin
    Topical coal tar and topical calcipotriol + oral metformin 850mg twice daily
    Interventions:
    • Drug: Metformin
    • Drug: Topical Coal tar
    • Drug: Topical calcipotriol
  • Placebo Comparator: Placebo
    Topical coal tar and topical calcipotriol
    Interventions:
    • Drug: Placebo
    • Drug: Topical Coal tar
    • Drug: Topical calcipotriol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644954
Other Study ID Numbers  ICMJE NK/1842/Res/1096
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sunil Dogra, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunil Dogra, MD Postgraduate Institute of Medical Education and Research
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP