Pioglitazone in Psoriasis- A Clinical and Molecular Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133561
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : February 23, 2011
Information provided by:
Cairo University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: actozone A Drug: actozone B Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: actozone A
Pioglitazone 30 mg tablets daily
Drug: actozone A
pioglitazone 30 mg tablet , once daily dose for 10 weeks

Placebo Comparator: actozone B
Drug: actozone B
one tablet of vehicle without active ingredient pioglitazone

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133561

Dermatology department of cairo university faculty of medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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

Responsible Party: Vanessa Galal Hafez/ Assistant lecturer of Dermatology, Dermatology department, Faculty of medicine, Cairo university Identifier: NCT01133561     History of Changes
Other Study ID Numbers: VHafez 2010
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

Keywords provided by Cairo University:
insulin resistance
metabolic syndrome
randomized control trial

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs