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IRCT20181208041882N14 IRCT 2023-10-16 Yazd University of Medical Sciences The effect of vitamin E in the treatment of radiotherapy dermatitis Evaluation of Topical vitamin E and zinc oxide versus zinc oxide in treatment of radiation dermatitis: a double-blind clinical trial 2018-04-21 anticipated 56 Complete https://irct.ir/trial/68266 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 56 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 12 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 56 is in 12 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 56, Blinding description: In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received. The patients in the two groups received the medications in the same packaging. 3 Dermatitis caused by breast radiation therapy. Intervention 1: Intervention group: The patient receives topical ointment of vitamin E 18% and zinc oxide 20% (manufactured in Yazd Faculty of Pharmacy) twice daily from the first day of radiation therapy for four weeks. Intervention 2: Control group: The patient receives 20% zinc oxide topical ointment (manufactured in Yazd Faculty of Pharmacy) twice a day from the first day of radiation therapy for four weeks. Yes - There is a plan to make this available What will be shared: After nonrecognition, all data can be share When: 6 months after publication To whom: All of researchers Conditions: nothing Where to obtain: Behrooz Heydari email: b.heydari@ssu.ac.ir How to obtain: Request your information by email. The data will be sent after a week. Comments:
public Behrooz Heydari
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences scientific Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 8915173143 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with grade 1 to 2 skin dermatitis caused by radiotherapy Patients aged 18 to 65 years 18 years 65 years Both Patients with skin disease hypersensitivity to vitamin E or zinc oxide Severe systemic disease such as uncontrolled diabetes L58 Radiodermatitis Treatment - Drugs Treatment - Drugs Intervention group: The patient receives topical ointment of vitamin E 18% and zinc oxide 20% (manufactured in Yazd Faculty of Pharmacy) twice daily from the first day of radiation therapy for four weeks. Control group: The patient receives 20% zinc oxide topical ointment (manufactured in Yazd Faculty of Pharmacy) twice a day from the first day of radiation therapy for four weeks. Intensity of redness. Timepoint: Weeks 0, 1, 2, 3, 4. Method of measurement: RTOG standard scale. Itching intensity. Timepoint: Weeks 0,1,2,3,4. Method of measurement: Based on visual analog scale. Intensity of burning. Timepoint: Weeks 0,1,2,3,4. Method of measurement: Based on visual analog scale. Intensity of pain. Timepoint: Weeks 0,1,2,3,4. Method of measurement: Based on visual analog scale. Yazd University of Medical Sciences Approved 2018-01-10 Ethics committee of Yazd University of Medical Sciences Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq Yazd Yazd Iran (Islamic Republic of)