Skip to main content
OpenTrials
Completed

NCT Number: NCT01133561

Pioglitazone in Psoriasis- A Clinical and Molecular Study.

The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.

The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology department of cairo university faculty of medicine

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years and less than 65 years.
  • Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).

Exclusion criteria

  • Age less than 18 years and more than 65 years
  • Mild psoriasis less than 10% body surface area
  • Erythrodermic or pustular psoriasis
  • Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
  • Pregnant and lactating females.

Treatment and study plan

actozone A

Drug

pioglitazone 30 mg tablet , once daily dose for 10 weeks

actozone B

Drug

one tablet of vehicle without active ingredient pioglitazone

Primary outcomes

  1. Treatment success detected as clinical improvement of skin condition

    Time frame: 10 weeks

    PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50

Secondary outcomes

  1. Fasting serum insulin reduction from baseline before treatment

    Time frame: 10 weeks

  2. C-reactive protein titre reduction from baseline value before treatment

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 31, 2010
Registry last updated
Feb 23, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.