This study is a before-after clinical trial. The participants receive 30 mg/day of pioglitazone for 30 month (12 weeks) after evaluating inclusion and exclusion criteria and completing consent form. The PASI score and plaques specifications of patients are recorded monthly. In each visit the amount of scales, erythema and thickness of lesions and covering percentage are recorded into the checklists. Physical examinations and laboratory findings are entered in tables at each session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903013862N2
Registration date:2010-06-08, 1389/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-08, 1389/03/18
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2007-09-26, 1386/07/04
Expected recruitment end date
2010-11-25, 1389/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy and side effects of Pioglitazone in the treatment of plaque psoriasis vulgaris
Public title
Study of efficacy and side effects of Pioglitazone in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: new cases of plaque psoriasis which don’t received systematic treatment during last 3 months and for topical treatment last month, patients complete consent form and participate to study consciously. Exclusion criteria: patients who want to leave study deliberately, sensitive to pioglitazone or the same preparations, type one diabetes mellitus, pregnant or lactating women, below 18 years old, with severe hepatic problems (hepatitis, alcoholic or non alcoholic steatohepatitis, cirrhosis), severe cardiovascular disorders (NYHA CLASS III & IV), patients prevent pregnancy only by oral contraceptives, patients that have any of these following side effects during therapy: upper respiratory tract infections and sinusitis, edema and any indicative sign of heart failure, unwanted pregnancy, weight gain, anemia, leuckopenia, hematuria, jaundice and 3 times increment of hepatic enzymes (ALT), any symptom which make patients to leave the study. Patients who used any of these drugs (Oral contraceptives, Gatifloxacin ,Insulin ,sulfunamides ,sulfunylureas, Thioridazine , Gemfibrozil).
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences, Mashad, Iran
City
Mashhad
Postal code
Approval date
2007-10-26, 1386/08/04
Ethics committee reference number
286255
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
Psoriasis severity
Timepoint
monthly untill the end of 12 weeks
Method of measurement
PASI standard method
Secondary outcomes
1
Description
side effect
Timepoint
monthly untill end of 12 weeks
Method of measurement
Standard evaluation method for this disease
Intervention groups
1
Description
oral Pioglitazone 30 mg daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of skin disease and cutaneous leishmaniasis, Ghaem Hospital
Full name of responsible person
Dr Pouran Layegh, Dr sayed Rahman Movahed Ghodsi nia
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Scinences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and leishmaniasis, Office building, Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1732 7027
Fax
Email
hadis_yousefzadeh@yaoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1881 4988
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center for skin disease and cutaneous leihmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and leishmaniasis, Office building, Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)