Determination of oral methotrexate and phototherapy effect on vitiligo in comparison with phototherapy alone.
Design
Two arm parallel group randomized trial. Double blinded
Settings and conduct
The vitiligo patents of Razi hospital who were candidate for phototherapy were randomly divided in two groups. One group of patients received placebo with phototherapy for three times a week another group of patents received methotrexate and phototherapy. None of patients and researchers know about allocation.
Participants/Inclusion and exclusion criteria
Older than 18 y/o
Patients who are candidate for phototherapy.
Vitiligo disease activity more than one.
Patients who don’t have receive immunosuppressive treatment in the six past month.
Intervention groups
Patients were divided into two groups. control group received placebo and phototherapy three times a week. Phototherapy was done using 12 lamps emitting ultraviolet beam with wavelengths between 310 -315 nanometers. another group of patients receive 12.5 milligrams methotrexate weekly and phototherapy three times a week. UV eye glasses were used to protect eyes.
Intervention group received phototherapy three times a week and 12.5 mg methotrexate weekly.
Patients consume Five 2.5 mg methotrexate tablets on Fridays and one acid folic tablet on sundays.
Main outcome variables
Treatment
Systemic disease
Vitiligo Area Scoring Index
Vitiligo Disease Activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221013056158N1
Registration date:2022-12-11, 1401/09/20
Registration timing:retrospective
Last update:2022-12-11, 1401/09/20
Update count:0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Zahra Sadat Seyedhoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 1975
Email address
hoseini9020@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-03-21, 1401/01/01
Scientific title
Study of methotrexate with phototherapy on vitiligo patients in comparison with phototherapy alone.
Public title
Study of combined methotrexate and phototherapy in vitiligo.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Known case of vitiligo
No systemic or local immunosuppressive treatment in past 6 months
Vitiligo disease activity more than one
Candidates for phototherapy
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used in this study. in this method simple randomization models like tossing a coin, using randomized number tables or computerized methods of randomization is used. In this method each case is allocated in one group( control or intervention ) by tossing a coin for example.
Some advantages of this method are unpredictability of treatment used for each case. Implementing of this method is simple.
Randomization unit of this study is each case.
Randomizer software was used for randomization. This software gives us the ability to choose a desired method of randomization among several others.
Randomization sequence was created using randomizer software. The sequence was created asking the software to divide 42 cases into two groups of 21 equally. The software allocated each case to control or intervention group randomly.
Central allocation concealment was used in this study. In this method randomization sequence is within a central group other than researchers. Researchers make contact to the central group in order to ask next case allocated group according to the sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher did not know which group gut methotrexate and which group gut placebo.
Patients did not know what kind of treatment they received.
Placebo and methotrexate were given to patients by third person.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, Vahdat Eslami Ave., Razi hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1358
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of vitiligo disease
Timepoint
Before treatment, after 2 months, 4 months and 6 months of treatment.
Method of measurement
Vitiligo Area Scoring Index
2
Description
Vitiligo activity
Timepoint
Before treatment then after 2 months, 4 months and 6 months of treatment.
Method of measurement
Vitiligo Disease Activity Scorings
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitiligo patients in this group received phototherapy twice a week and oral methotrexate 12/5 milligrams in a week.
Category
Treatment - Drugs
2
Description
Control group: Vitiligo patients in this group received phototherapy twice a week and placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Zahrasadat Seyedhoseini
Street address
Vahdat eslami Ave.,Razi hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Keshavarz Blv., 16 Azar Ave.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Keshavarz Blv., 16 Azar Ave.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahrasadat Seyedhoseini
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tehran, Razi Ave., Razi hospital.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9952
Email
hoseini9020@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Sadat Seyedhoseini
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 57, Ekhtiyariyeh Ave
City
Tehran
Province
Tehran
Postal code
1945853547
Phone
+98 31 3650 1975
Fax
Email
hoseini9020@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Sadat Seyedhoseini
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 57, Ekhtiyariyeh Ave
City
Tehran
Province
Tehran
Postal code
1945853547
Phone
+98 31 3650 1975
Fax
Email
hoseini9020@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of cases will be publish. Variables include age, sex, past medical history, received treatment.
When the data will become available and for how long
6 months after publish.
To whom data/document is available
Researchers of scientific centers and universities.
Under which criteria data/document could be used
University professor and researchers can have access to data for research purposes. Systematic review analyses can be performed on the data.
From where data/document is obtainable
Researchers can ask to receive data through email address hoseini9020@yahoo.com.
What processes are involved for a request to access data/document
Researchers who want to receive data must send his or her scientific resume. After assessment we will reply in one week.