Pioglitazone in Psoriasis- A Clinical and Molecular Study.

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01133561
First received: May 25, 2010
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Psoriasis
Drug: actozone A
Drug: actozone B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Treatment success detected as clinical improvement of skin condition [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50


Secondary Outcome Measures:
  • Fasting serum insulin reduction from baseline before treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein titre reduction from baseline value before treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: actozone A
Pioglitazone 30 mg tablets daily
Drug: actozone A
pioglitazone 30 mg tablet , once daily dose for 10 weeks
Placebo Comparator: actozone B
placebo
Drug: actozone B
one tablet of vehicle without active ingredient pioglitazone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133561

Locations
Egypt
Dermatology department of cairo university faculty of medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Manal AW Bosseila, MD Cairo University-Dermatology department
Study Director: 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
  More Information

No publications provided

Responsible Party: Vanessa Galal Hafez/ Assistant lecturer of Dermatology, Dermatology department, Faculty of medicine, Cairo university
ClinicalTrials.gov Identifier: NCT01133561     History of Changes
Other Study ID Numbers: VHafez 2010
Study First Received: May 25, 2010
Last Updated: February 22, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
psoriasis
insulin resistance
metabolic syndrome
pioglitazone
randomized control trial

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014