Pioglitazone in Psoriasis- A Clinical and Molecular Study.

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133561
• Other study ID #: VHafez 2010
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: February 22, 2011
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• actozone A
pioglitazone 30 mg tablet , once daily dose for 10 weeks
• actozone B
one tablet of vehicle without active ingredient pioglitazone

Locations

Country	Name	City	State
Egypt	Dermatology department of cairo university faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fasting serum insulin reduction from baseline before treatment		10 weeks	No
Secondary	C-reactive protein titre reduction from baseline value before treatment		10 weeks	No