Pioglitazone in Psoriasis- A Clinical and Molecular Study.

NCT ID: NCT01133561

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

actozone A

Pioglitazone 30 mg tablets daily

Group Type: ACTIVE_COMPARATOR

actozone A

Intervention Type: DRUG

pioglitazone 30 mg tablet , once daily dose for 10 weeks

actozone B

placebo

Group Type: PLACEBO_COMPARATOR

actozone B

Intervention Type: DRUG

one tablet of vehicle without active ingredient pioglitazone

Interventions

actozone A

pioglitazone 30 mg tablet , once daily dose for 10 weeks

Intervention Type: DRUG

actozone B

one tablet of vehicle without active ingredient pioglitazone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dermatology department, Faculty of medicine, Cairo university

Principal Investigators

Manal AW Bosseila, MD

Role: STUDY_CHAIR

Cairo University-Dermatology department

Mona RE Abdel Halim, MD

Role: STUDY_DIRECTOR

Cairo university- Dermatology department

Mohamed I Sheta, MD

Role: STUDY_DIRECTOR

Cairo university- Internal medicine department

Olfat G Shaker, MD

Role: STUDY_DIRECTOR

Cairo University- Biochemistry department

Locations

Dermatology department of cairo university faculty of medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

VHafez 2010

Identifier Type: -

Identifier Source: org_study_id