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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: actozone A; Drug: actozone B

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dermatology department of cairo university faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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; placebo	Drug: actozone B; one tablet of vehicle without active ingredient pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success detected as clinical improvement of skin condition	PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting serum insulin reduction from baseline before treatment	10 weeks
C-reactive protein titre reduction from baseline value before treatment	10 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: insulin resistance; metabolic syndrome; psoriasis; pioglitazone; randomized control trial
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: VHafez 2010