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IRCT20150304021338N3 IRCT 2021-09-20 Esfahan University of Medical Sciences The effect of topical vitamin K on skin rash Comparative study of the effect of topical vitamin K with placebo in the treatment of skin rash in patients with metastatic colon cancer treated with Cetuximab 2021-09-16 anticipated 48 Complete https://irct.ir/trial/58218 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients wish to participate in the study will be randomly divided into two groups A and B, using Random allocation software. Patients will be randomly assigned to intervention or control groups by someone other than the main researcher and statistical analyst, so, the patient, main researcher and statistical analyst will not know that how patients are placed in each group (intervention or control), Blinding description: In this study, two drugs, topical Vitamin K cream and placebo, in terms of shape and color, are prepared in the same way and provided to the researcher. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Skin rash. Intervention 1: Intervention group: Patients with skin rash has been induced by Cetuximab,will use topical 0.1% vitamin K cream, including a combination of vitamin K1 (Phytonadione) produced by Caspian company and the cream base,twice a day for 8 weeks. Intervention 2: Control group: Patients with skin rash has been induced by Cetuximab, will use topical cream, including cream base And without any other additives, twice a day for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahmoud Rezaei
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3235 0214 dralirezarezaei1991@gmail.com Esfahan University of Medical Sciences scientific Mahmoud Rezaei
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3235 0214 dralirezarezaei1991@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with metastatic colorectal cancer that are candidates for treatment with Cetuximab . Patients with grade 1 to 4 skin lesions, after using Cetuximab(based on Common Terminology Criteria for Adverse Events4 (CTCAE4)) Be over 18 years old The patient should not undergo radiotherapy. Have a desire to participate in the study. 18 years no limit Both The patient has skin lesions before receiving cetuximab (including rash, acne, pustules, inflammatory erythema) Being pregnant or in breastfeeding duration Previous history of allergies to compounds containing vitamin K Has a psychiatric disorder that is not able to participate in the study For other reasons, he is taking drugs that have a drug interaction with topical vitamin K Be taking medicinal compounds containing vitamin K R21 Rash and other nonspecific skin eruption Treatment - Drugs Treatment - Drugs Intervention group: Patients with skin rash has been induced by Cetuximab,will use topical 0.1% vitamin K cream, including a combination of vitamin K1 (Phytonadione) produced by Caspian company and the cream base,twice a day for 8 weeks. Control group: Patients with skin rash has been induced by Cetuximab, will use topical cream, including cream base And without any other additives, twice a day for 8 weeks. Grade of skin lesions, based on Common Terminology Criteria for Adverse Events4 (CTCAE4). Timepoint: At the beginning of the study and 4 and 8 weeks after using topical vitamin K. Method of measurement: Based on CTCEA4. Esfahan University of Medical Sciences Approved 2021-07-16 Center of Medical Research - Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)