Pioglitazone in Psoriasis- A Clinical and Molecular Study.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01133561

Enrollment

Registered

2010-05-31

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial

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.

Interventions

DRUGactozone A

pioglitazone 30 mg tablet , once daily dose for 10 weeks

DRUGactozone B

one tablet of vehicle without active ingredient pioglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026