]>
IRCT20221013056158N1 IRCT 2022-12-11 Tehran University of Medical Sciences Study of combined methotrexate and phototherapy in vitiligo. Study of methotrexate with phototherapy on vitiligo patients in comparison with phototherapy alone. 2021-03-21 anticipated 42 Complete https://irct.ir/trial/66388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, 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 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. 3 Vitiligo. Intervention 1: Intervention group: Vitiligo patients in this group received phototherapy twice a week and oral methotrexate 12/5 milligrams in a week. Intervention 2: Control group: Vitiligo patients in this group received phototherapy twice a week and placebo. Yes - There is a plan to make this available What will be shared: Individual data of cases will be publish. Variables include age, sex, past medical history, received treatment. When: 6 months after publish. To whom: Researchers of scientific centers and universities. Conditions: University professor and researchers can have access to data for research purposes. Systematic review analyses can be performed on the data. Where to obtain: Researchers can ask to receive data through email address hoseini9020@yahoo.com. How to obtain: Researchers who want to receive data must send his or her scientific resume. After assessment we will reply in one week. Comments:
public Zahrasadat Seyedhoseini
Tehran, Razi Ave., Razi hospital.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5560 9952 hoseini9020@yahoo.com Tehran University of Medical Sciences scientific Zahra Sadat Seyedhoseini
No. 57, Ekhtiyariyeh Ave
Tehran Iran (Islamic Republic of) 1945853547 +98 31 3650 1975 hoseini9020@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Known case of vitiligo No systemic or local immunosuppressive treatment in past 6 months Vitiligo disease activity more than one Candidates for phototherapy 18 years no limit Both Treatment - Drugs Placebo Intervention group: Vitiligo patients in this group received phototherapy twice a week and oral methotrexate 12/5 milligrams in a week. Control group: Vitiligo patients in this group received phototherapy twice a week and placebo. Severity of vitiligo disease. Timepoint: Before treatment, after 2 months, 4 months and 6 months of treatment. Method of measurement: Vitiligo Area Scoring Index. Vitiligo activity. Timepoint: Before treatment then after 2 months, 4 months and 6 months of treatment. Method of measurement: Vitiligo Disease Activity Scorings. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2022-02-16 Ethics committee of Tehran University of Medical Sciences Tehran, Vahdat Eslami Ave., Razi hospital Tehran Tehran Iran (Islamic Republic of)