Pioglitazone in Psoriasis- A Clinical and Molecular Study.
This study has been completed.
Sponsor:
Cairo University
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01133561
First received: May 25, 2010
Last updated: February 22, 2011
Last verified: February 2011
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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
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, Papulosquamous Skin Diseases Pioglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013