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IRCT20211024052859N1 IRCT 2022-01-19 Mashhad University of Medical Sciences The effect of 15% TCA peel on phototherapy of patients with acral vitiligo Evaluation of the additional effect of 15% TCA peel on response to phototherapy of patients with acral vitiligo 2022-02-04 anticipated 40 Complete https://irct.ir/trial/59974 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. In this website, the number of participants along with the number of groups are entered. Then for each group, a number of codes will be generated randomly. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on the type of intervention, receives phototherapy and 15% TCA peel for organs of one side as intervention and only phototherapy for the other side of body as control group. Randomization only takes place to select the right or left limb, Blinding description: In this study only outcome assessors, when evaluating the patients, will be unaware of how patients are grouped and which treatment they receive. No placebo drug will be used in this study. 2-3 acral vitiligo. Intervention 1: Intervention group: In this group, for one side of the patient's body (either the left or the right limb) which will be determined after randomization, treatment with 15% TCA peel will be performed once a week for 1 month. Then, after 10 to 15 days, phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. Intervention 2: Control group: In this group, for the limb opposing the one in the in the intervention group, only phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Yasaman Rastegar
Ghaem hospital, Ahmadabad street, Mashhad
Mashhad Iran (Islamic Republic of) 9176999311 +98 71 3649 0953 Rastegary971@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Yalda Nahidi
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 nahidiy@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with acral vitiligo Age is over 12 years 12 years no limit Both Patients with a history of Koebner phenomenon Patients with a history of keloids Pregnancy Photosensitivity L80 Vitiligo Treatment - Drugs Treatment - Drugs Intervention group: In this group, for one side of the patient's body (either the left or the right limb) which will be determined after randomization, treatment with 15% TCA peel will be performed once a week for 1 month. Then, after 10 to 15 days, phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. Control group: In this group, for the limb opposing the one in the in the intervention group, only phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. Size of vitiligo lesions. Timepoint: At the beginning of the study and after 6 months of phototherapy. Method of measurement: Images taken before and after the intervention are compared between the two groups after 6 months of phototherapy by two physicians outside the study based on the rate of repigmentation. The ideal response is above 75% repigmentation. Mashhad University of Medical Sciences Approved 2021-04-13 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)