Pioglitazone in Psoriasis- A Clinical and Molecular Study.

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Drug: actozone A; Drug: actozone B

• Registration Number: NCT01133561
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
actozone A	actozone A	Pioglitazone 30 mg tablets daily
actozone B	actozone B	placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fasting serum insulin reduction from baseline before treatment	10 weeks
C-reactive protein titre reduction from baseline value before treatment	10 weeks

Trial Locations

Locations (1)

Dermatology department of cairo university faculty of medicine; 🇪🇬 Cairo, Egypt