Clinical trial of comparison of the efficacy of NBUVB phototherapy plus pioglitazone versus NBUVB phototherapy alone in the reduction of PASI score in patients with plaque type psoriasis
Psoriasis is a chronic debilitating disease that can affect up to 2% of the population. Treatment with NBUVB is a well-recognized treatment for plaque type psoriasis. Pioglitazone is a thiazolidinedione insulin sensitizing agent that has shown to be an effective and safe treatment option in chronic plaque-type psoriasis. The underlying mechanism for this treatment is the anti proliferative, anti-inflammatory and anti angiogenic effects of pioglitazone. We have designed this randomized, double blind clinical trial to evaluate and compare the efficacy of a combination of NBUVB plus pioglitazone and NBUVB alone in the treatment of plaque type psoriasis. A total of 74 adult patients with plaque type psoriasis will be included and allocated randomly in to two groups. One group will be treated with NBUVB plus pioglitazone and the other group will be treated with NBUVB plus placebo. After 30 sessions of NBUVB the efficacy of treatment will be compared between groups in terms of the percentage of patients who achieve Psoriasis Area and Severity Index (PASI) 75. Improvement observed in PASI score will be documented and compared between two groups. The DLQI (Dermatology Life Quality Index) of the patients and adverse effects of treatment will also be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091918607N2
Registration date:2017-02-28, 1395/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-28, 1395/12/10
Registrant information
Name
Maryam Ghiasi
Name of organization / entity
Tehran University of Medical Sciences, Department of Dermatology, Razi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
mghiasi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of the efficacy of NBUVB phototherapy plus pioglitazone versus NBUVB phototherapy alone in the reduction of PASI score in patients with plaque type psoriasis
Public title
Evaluation of the efficacy of NBUVB (narrow band UVB) phototherapy plus pioglitazone versus NBUVB phototherapy alone in the treatment of plaque type psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with plaque type psoriasis; indication of NBUVB phototherapy
Exclusion criteria: age under 18 years; treatment with phototherapy or systemic drugs of psoriasis during the last 3 months; pregnancy; lactation; congestive heart failure; renal diseases; liver diseases; pulmonary diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Ghods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.856
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
PASI 75
Timepoint
Before treatment and 10 weeks after starting treatment
Method of measurement
Examination
Secondary outcomes
1
Description
Dermatology Life Quality Index (DLQI)
Timepoint
Before treatment and 10 weeks after starting treatment
Method of measurement
Questionnaire
2
Description
Adverse effects
Timepoint
every month after starting treatment
Method of measurement
examination and asking from the patients
Intervention groups
1
Description
Pioglitazone group: NBUVB phototherapy three times a week plus pioglitazone (tablet 30 mg, 1 tab/ day, oral)
Category
Treatment - Drugs
2
Description
Placebo group: NBUVB three times a week plus placebo (the same as pioglitazone)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Ghods St, Keshavarz Blvd, 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
Department of Dermatology, Tehran University of Medical Sciences
Full name of responsible person
Maryam Ghiasi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Department of Dermatology
Full name of responsible person
Maryam Ghiasi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Maryam Ghiasi
Position
Other areas of specialty/work
Street address
Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
City
Postal code
Phone
+98 21 5561 8989
Fax
Email
mghiasi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)