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Pioglitazone in Psoriasis- A Clinical and Molecular Study.

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01133561
First received: May 25, 2010
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

May 25, 2010
February 22, 2011
January 2010
July 2010   (final data collection date for primary outcome measure)
Treatment success detected as clinical improvement of skin condition [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50
Same as current
Complete list of historical versions of study NCT01133561 on ClinicalTrials.gov Archive Site
  • Fasting serum insulin reduction from baseline before treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein titre reduction from baseline value before treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: actozone A
    pioglitazone 30 mg tablet , once daily dose for 10 weeks
  • Drug: actozone B
    one tablet of vehicle without active ingredient pioglitazone
  • Active Comparator: actozone A
    Pioglitazone 30 mg tablets daily
    Intervention: Drug: actozone A
  • Placebo Comparator: actozone B
    placebo
    Intervention: Drug: actozone B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01133561
VHafez 2010
Yes
Vanessa Galal Hafez/ Assistant lecturer of Dermatology, Dermatology department, Faculty of medicine, Cairo university
Cairo University
Not Provided
Study Chair: Manal AW Bosseila, MD Cairo University-Dermatology department
Study Director: Mona RE Abdel Halim, MD Cairo university- Dermatology department
Study Director: Mohamed I Sheta, MD Cairo university- Internal medicine department
Study Director: Olfat G Shaker, MD Cairo University- Biochemistry department
Cairo University
February 2011

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