Back to resultsPioglitazone in Psoriasis- A Clinical and Molecular Study.
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
actozone A
actozone B
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial
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.
Sites / Locations
- Dermatology department of cairo university faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
actozone A
actozone B
Arm Description
Pioglitazone 30 mg tablets daily
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Fasting serum insulin reduction from baseline before treatment
C-reactive protein titre reduction from baseline value before treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01133561
Brief Title
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
Official Title
The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
actozone A
Arm Type
Active Comparator
Arm Description
Pioglitazone 30 mg tablets daily
Arm Title
actozone B
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
actozone A
Intervention Description
pioglitazone 30 mg tablet , once daily dose for 10 weeks
Intervention Type
Drug
Intervention Name(s)
actozone B
Intervention Description
one tablet of vehicle without active ingredient pioglitazone
Primary Outcome Measure Information:
Title
Treatment success detected as clinical improvement of skin condition
Description
PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Fasting serum insulin reduction from baseline before treatment
Time Frame
10 weeks
Title
C-reactive protein titre reduction from baseline value before treatment
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal AW Bosseila, MD
Organizational Affiliation
Cairo University-Dermatology department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona RE Abdel Halim, MD
Organizational Affiliation
Cairo university- Dermatology department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed I Sheta, MD
Organizational Affiliation
Cairo university- Internal medicine department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olfat G Shaker, MD
Organizational Affiliation
Cairo University- Biochemistry department
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology department of cairo university faculty of medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pioglitazone in Psoriasis- A Clinical and Molecular Study.
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