Pioglitazone in Psoriasis- A Clinical and Molecular Study. | NCT01133561

Studies
Pioglitazone in Psoriasis- A Clinical and Molecular Study.

NCT01133561

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 23, 2011Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Psoriasis

Interventions

actozone A
actozone B

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

May 25, 2010

First Submission Date that Met QC Criteria

May 28, 2010

First Posted Date

May 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
actozone A	Active Comparator	Pioglitazone 30 mg tablets daily	Drug: actozone A
actozone B	Placebo Comparator	placebo	Drug: actozone B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
actozone A	Drug	pioglitazone 30 mg tablet , once daily dose for 10 weeks	actozone A

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manal AW Bosseila, MD	Cairo University-Dermatology department	Study Chair
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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology department of cairo university faculty of medicine		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis
D007333	Insulin Resistance
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided