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IRCT20181208041882N19 IRCT 2023-11-05 Yazd University of Medical Sciences The effect of topical cholestyramine in the treatment of diaper dermatitis Comparison of topical cholestyramine and zinc oxide in the treatment of diaper dermatitis from diarrhea: a randomized, double-blind clinical trial. 2017-12-22 anticipated 70 Complete https://irct.ir/trial/68264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 70 patients were randomly assigned to two treatment groups A and B. For random allocation, block random allocation method was used. In this study, 10 blocks of size 7 were considered. The generated permutations include letters A and B that are repeated. These permutations were produced with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from number 1 to 70, which are placed in 10 blocks of size seven. To implement this software output, we will give the first qualified person number 1 and the last person will receive number 70, Blinding description: The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and puts Cholestyramine and zinc oxide cream (the same in terms of color and smell) in the same shape boxes for patient consumption. And identifies them with codes A or B. The student then delivers the appropriate medications to the patients. 3 Diaper rash. Intervention 1: Intervention group: 5% cholestyramine cream formulation (manufactured in Yazd Faculty of Pharmacy), use topically after each diaper change for 5 days. Intervention 2: Control group: Topical zinc oxide ointment 20% (Caspian Company), applied topically after each diaper change for 5 days. Yes - There is a plan to make this available What will be shared: After making individuals unrecognizable, all data can be shared When: Six 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 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Age less than 24 months Diaper dermatitis in children with diarrhea no limit 24 months Both Skin diseases, kidney diseases, birth defects, oral or genital candidiasis Use of other drugs to treat diaper dermatitis Use of topical antibiotics in the area of diaper dermatitis L22 Diaper dermatitis Treatment - Drugs Treatment - Drugs Intervention group: 5% cholestyramine cream formulation (manufactured in Yazd Faculty of Pharmacy), use topically after each diaper change for 5 days Control group: Topical zinc oxide ointment 20% (Caspian Company), applied topically after each diaper change for 5 days Erythema severity. Timepoint: Days one, three and five after the intervention. Method of measurement: Based on scoring the severity of diaper dermatitis scale. Patients' recovery compared to the first day of intervention. Timepoint: The first, third and fifth day after intervention. Method of measurement: Observation and comparison of erythema severity, extent of dermatitis and clinical manifestations. Yazd University of Medical Sciences Approved 2017-11-29 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)