Pioglitazone in Psoriasis- A Clinical and Molecular Study.

NCT01133561 | Completed DMC

• 1 other identifier: VHafez 2010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Fasting serum insulin reduction from baseline before treatment

  10 weeks

• C-reactive protein titre reduction from baseline value before treatment

  10 weeks

Study Arms (2)

actozone A

ACTIVE COMPARATOR

Pioglitazone 30 mg tablets daily

Drug: actozone A

actozone B

PLACEBO COMPARATOR

placebo

Drug: actozone B

Interventions

actozone A DRUG

pioglitazone 30 mg tablet , once daily dose for 10 weeks

actozone A

actozone B DRUG

one tablet of vehicle without active ingredient pioglitazone

actozone B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and less than 65 years.
• Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology department of cairo university faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Psoriasis; Insulin Resistance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 31, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 23, 2011

Record last verified: 2011-02

Locations

EG (1)