This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Pioglitazone in Psoriasis- A Clinical and Molecular Study.

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

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: 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 ]
    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 ]
  • C-reactive protein titre reduction from baseline value before treatment [ Time Frame: 10 weeks ]

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
Drug: actozone B
one tablet of vehicle without active ingredient pioglitazone


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01133561

Dermatology department of cairo university faculty of medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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

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

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

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017