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OpenTrials
Completed

NCT Number: NCT00395941

Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PGIMER

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic plaque type psoriasis having body surface area involvement of > 20%
  • Patients of either sex
  • Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
  • Age range 18-65 years

Exclusion criteria

  • Females of child bearing potential
  • H/O hypersensitivity to acitretin
  • Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal)
  • Impaired renal function (serum creatinine >1.5mg% in males and >1.4 mg% in females)
  • Hyperlipidemia
  • BMI >30 kg /m2
  • H/O excessive alcohol use
  • Diabetes mellitus
  • Congestive heart failure
  • Ischemic heart disease

Treatment and study plan

pioglitazone

Drug

acitretin

Drug

Acitretin

Primary outcomes

  1. Change in PASI score from baseline in the two groups

    Time frame: 12 weeks

Secondary outcomes

  1. Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2006
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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