Protocol summary

Summary
The aim of this single-blind single-center study is to evaluate the effect of pioglitazone in psoriasis. To do this, 40 patients with plaque type psoriasis who have indication for systemic therapy and not treated with phototherapy or any systemic agent in last 6 months are recruited. After preliminary evaluations (history, physical examination, CBC, blood biochemistry, etc.) those who have renal or hepatic disease, abnormal hepatic enzymes or any major systemic disease will be excluded. Then patients are assigned to one of the study groups (pioglitazone plus methotrexate or methotrexate alone) by block randomization. During the study if any of these major side effects occur, such as weight gain due to fluid retention and edema, decrease in Hb, WBC, or Plt, or significant increase in hepatic enzymes (more than 2.5 times of the baseline), the patient will be removed from the study. At 1, 2, 4, 6, 10 and 16 weeks patients are evaluated by psoriasis area and severity index (PASI) and dermatology life quality index (DLQI) scores and finally these two groups are compared and analyzed in terms of these scores.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202279149N1
Registration date: 2012-05-26, 1391/03/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-26, 1391/03/06
Registrant information
Name
Soroush Daklan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8786
Email address
daklan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-08-05, 1391/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of methotrexate plus pioglitazone in comparison with methotrexate alone in the management of patients with psoriasis vulgaris: a randomized controlled trial
Public title
The effect of pioglitazone in psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: plaque type psoriasis; Indication for systemic therapy; Phototherapy contraindicated; No systemic therapy or phototherapy in last 6 months Exclusion criteria: congestive heart failure; renal disease ; hepatic or pulmonary disease; abnormal hepatic enzymes; diabetes; pregnancy or lactation; potential for childbearing; any other major systemic diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of medical sciences
Street address
Tehran University of medical sciences, Ghods Avenue, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
90/د /130/1727

Health conditions studied

1

Description of health condition studied
psoriasis
ICD-10 code
L40.0
ICD-10 code description
Plaque psoriasis

Primary outcomes

1

Description
psoriasis area and severity index (PASI)
Timepoint
at weeks 0, 6, 10, 16
Method of measurement
PASI meter

2

Description
dermatology life quality index (DLQI)
Timepoint
at weeks 0,6,10,16
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Hepatic enzymes
Timepoint
at weeks 0, 1,2,4,6,10,16
Method of measurement
blood biochemistry

2

Description
complete blood cells (CBC)
Timepoint
at weeks 0,1,2,4,6,10,16
Method of measurement
automated analyzer (Automated blood count)

3

Description
lipid profile
Timepoint
at weeks, 0, 6,10, 16
Method of measurement
Lipid Blood Tests

4

Description
Bun and creatinine
Timepoint
at weeks 0,6,10,16
Method of measurement
blood biochemistry

5

Description
urine analysis
Timepoint
at weeks 0,6,10,16
Method of measurement
Urine test strip

Intervention groups

1

Description
oral methotrexate 7.5 t0 15 mg per week for intervention group for 16 weeks, pioglitazone 30 mg per day orally for 16 weeks.
Category
Treatment - Drugs

2

Description
oral methotrexate 7.5 t0 15 mg per week for control group for 16 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Soroush Daklan
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods Avenue, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soroush Daklan
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Razi hospital, Vahdat-e-eslami Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5560 9951
Fax
Email
daklan@razi.tums.ac.ir soroush.daklan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soroush Daklan
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Razi hospital, Vahdat-e-eslami Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5560 9951
Fax
Email
daklan@razi.tums.ac.ir soroush.daklan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soroush Daklan
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Razi hospital, Vahdat-e-eslami Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5560 9951
Fax
Email
daklan@razi.tums.ac.ir soroush.daklan@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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