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IRCT20150825023753N27 IRCT 2025-04-20 Shiraz University of Medical Sciences Effect of tofacitinib in the treatment of patients with vitiligo Evaluation of the effect of tofacitinib ointment in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy 2025-05-21 anticipated 46 Complete https://irct.ir/trial/82551 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, selected patients must have at least ۲ similar lesions of the same color and size; therefore, one of the lesions on one side of the body as an intervention and the lesion on the other side will be selected as a control. Intervention lesions will be treated by tofacitinib ointment and control lesions by placebo, which is completely identical in shape, color and consistency to the original drug. In the information form, the lesions on each side of the patient will be marked with code ۱ and ۲, and two ointments will be distributed under the code A and B. The researcher will not know about the type of drug until the time of data analysis. To randomize the patients, the code number one belongs to the right side and number two to the left side. These two numbers are placed separately in a closed envelope. The letters A and B are placed separately in two envelopes .Each patient randomly chooses an envelope of numbers and an envelope of letters. Based on that Which number and which letter he chooses, the right or left side will be treated with ointment containing code A or B, Blinding description: Blinding will be done in such a way that the content of A and B ointments will be divided by the drug manufacturer, and only the drug manufacturer know about the content of the tubes .Collecting information before, ۴۵ days and ۹۰ days after the procedure will be done by the project executor and the patient and the project executor will not be aware of the type of ointments. In the data analysis stage, the project executor analysis the data with the name of the groups (so they will not be aware of the description of the operation). Therefore, this study is double-blind, and the contents of the two groups of ointments will not be known from the stage of the patient's entry into the study until the completion of the study, data collection and data analysis. 3 Vitiligo. Intervention 1: Intervention group: receiving daily tofacitinib ointment for three month. Intervention 2: Control group: receiving placebo daily for three month. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: starting 6 months after publication To whom: The data will be accessible to researchers working at academic and scientific institutions as well as those employed in the industry. Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments:
public Maryam Hekmat
Dermatology Ward of Shahid Faghihi Hospital,zand street
shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1099 m.hekmat1997@yahoo.com Shiraz University of Medical Sciences scientific Mehdi Ghahartars
The Dermatology Department of Faghihi Hospital, Zand Street,Shiraz
shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1099 Mghahar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over ۱۸ years Presence of depigmented lesions in the upper, lower limbs, face or trunk that are similar in size and color Not using any topical drugs in the last one month Stable or progressive course of the disease Involvement of at least ۲۰% of the body surface Consent to participate in this study 18 years no limit Both Any history of skin cancer or immunodeficiency, Unwillingness to participate in the study The impossibility of follow-up and refer for follow-up L80 Vitiligo Treatment - Drugs Placebo Intervention group: receiving daily tofacitinib ointment for three month. Control group: receiving placebo daily for three month. Vitiligo. Timepoint: 0,45,90 days later. Method of measurement: Physical exam. Vitiligo Area Scoring Index. Timepoint: 0,45,90 days later. Method of measurement: The information form for the Vitiligo Area Scoring Index (VASI). Shiraz University of Medical Sciences Approved 2024-08-30 Shiraz University Of Medical Science Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)