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IRCT20221018056230N1 IRCT 2022-11-26 Esfahan University of Medical Sciences Investigation of 4% topical sucralfate in the topical treatment of children with diaper dermatitis The Effect of 4% Topical Sucralfate in Erosive Candidial Diaper Dermatitis 2022-11-22 anticipated 32 Complete https://irct.ir/trial/66397 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Erosive Candidial Diaper Dermatitis. Intervention group: The medicine used is 4% sucralfate gel, the medicine will be applied every 4 or 5 hours when the child is awake, 5 times a day, in the affected area in the form of a thin layer covering the skin.The drug will be administered in the Faculty of Pharmacy of Isfahan University of Medical Sciences under the supervision of a pharmacist. To prepare one hundred grams of four percent sucralfate gel, first heat 85 ml of purified water on an electric heater until it reaches the boiling temperature, and after turning off the heat source at a temperature of 80 degrees Celsius, add 180 mg of methyl paraben and 20 A milligram of propyl paraben will be added to it, and then at a temperature of 50 degrees Celsius, one gram of carbomer 934, which has already been weighed, will be added to the formula.Half an hour later, that is, when the carbomer was hydrated, the formulation was stirred for 10 minutes with the help of a glass rod, and when the temperature of the formulation reached about 25 degrees Celsius, 4 grams of sucralfate powder, which was previously dissolved in ten milliliters of water, was added. The solution is added to the base and stirred with a glass rod for ten minutes until a homogeneous formulation is obtained. If the pH of the formulation is acidic, two drops of triethanolamine will be added and stirred to neutralize it. Finally, the final formulation will be packed in soft tubes. The contents on the tube box (consumer instructions) include the following: This medicine can only be used for skin use and under the supervision of a physician. In case of any skin reaction, consult the physician.The medicine should be stored at a temperature below 25 degrees Celsius and in a dry and cool place, away from direct sunlight and out of the reach of children. After opening the medicine tube, it can be used for up to one month at room temperature. Do not leave it in the environment and close it tightly. Avoid applying the medicine in sensitive areas such as around the eyes or on the face. Sample Size and Sampling Method: The sample size required for this study was calculated using the sample size estimation formula to compare the averages mentioned below and considering the confidence level of 95%, the power of the test is 80%, the average number of times for Improvement of lesions in a similar study and taking into account the minimum significant difference between the two groups of case and control for 1 day, the number of samples required in each of the case and control groups was estimated to be 22 people, taking into account 10% sample loss. Eligible people to enter the study are randomly assigned to each of the case and control groups in a random permutation block method with a size of 4. How to use the medicine:The medicine will be applied every 4 or 5 hours when the child is awake, 5 times a day, in the affected area in the form of a completely covering thin layer on the skin. Necessary training will be given to the mother on how to use the medicine during the first visit. How to teach: The health and preventive measures that will be taught to mothers along with taking medicine are as follows: using linen diapers or washable cotton diapers that are washed and rinsed with soap, changing diapers or diapers regularly. As soon as the infant or child urinates, a complete explanation of the causes of diaper dermatitis including detergents, urine, diarrhea, the infant, the type of feeding and the type of diaper or the age of the infant. The number of training sessions: It is proportional to the visits of patients with their parents.Study grouping: In this study, patients are randomly divided into two groups with equal numbers. Both groups received standard treatment for diaper dermatitis including topical clotrimazole three times a day. In addition to being treated with clotrimazole ointment three times a day (every 8 hours), the treatment group is also treated with topical sucralfate 4% every 4 or 5 hours when the child wakes up 5 times a day.. 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 After the conclusion of the effectiveness of the drug, a decision is made to release it
public Seyedeh Zahra Moosavi
Unit. 1, No.8, Alvan 14 Alley, Ebrahimi St, Marzdaran Blva
Tehran Iran (Islamic Republic of) 1461886681 +98 21 4429 9733 szm.gp68@yahoo.com Esfahan University of Medical Sciences scientific Seyedeh Zahra Moosavi
Unit. 1, No.8, Alvan 14 Alley, Ebrahimi St, Marzdaran Blva
Tehran Iran (Islamic Republic of) 1463735641 +98 21 4429 9733 szm.gp68@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children less than 2 years after infancy with a new clinical diagnosis of Candidiasis Rosacea due to diaper movement 30 days 2 years Both Treatment - Drugs Intervention group: The medicine used is 4% sucralfate gel, the medicine will be applied every 4 or 5 hours when the child is awake, 5 times a day, in the affected area in the form of a thin layer covering the skin.The drug will be administered in the Faculty of Pharmacy of Isfahan University of Medical Sciences under the supervision of a pharmacist. To prepare one hundred grams of four percent sucralfate gel, first heat 85 ml of purified water on an electric heater until it reaches the boiling temperature, and after turning off the heat source at a temperature of 80 degrees Celsius, add 180 mg of methyl paraben and 20 A milligram of propyl paraben will be added to it, and then at a temperature of 50 degrees Celsius, one gram of carbomer 934, which has already been weighed, will be added to the formula.Half an hour later, that is, when the carbomer was hydrated, the formulation was stirred for 10 minutes with the help of a glass rod, and when the temperature of the formulation reached about 25 degrees Celsius, 4 grams of sucralfate powder, which was previously dissolved in ten milliliters of water, was added. The solution is added to the base and stirred with a glass rod for ten minutes until a homogeneous formulation is obtained. If the pH of the formulation is acidic, two drops of triethanolamine will be added and stirred to neutralize it. Finally, the final formulation will be packed in soft tubes. The contents on the tube box (consumer instructions) include the following: This medicine can only be used for skin use and under the supervision of a physician. In case of any skin reaction, consult the physician.The medicine should be stored at a temperature below 25 degrees Celsius and in a dry and cool place, away from direct sunlight and out of the reach of children. After opening the medicine tube, it can be used for up to one month at room temperature. Do not leave it in the environment and close it tightly. Avoid applying the medicine in sensitive areas such as around the eyes or on the face. Sample Size and Sampling Method: The sample size required for this study was calculated using the sample size estimation formula to compare the averages mentioned below and considering the confidence level of 95%, the power of the test is 80%, the average number of times for Improvement of lesions in a similar study and taking into account the minimum significant difference between the two groups of case and control for 1 day, the number of samples required in each of the case and control groups was estimated to be 22 people, taking into account 10% sample loss. Eligible people to enter the study are randomly assigned to each of the case and control groups in a random permutation block method with a size of 4. How to use the medicine:The medicine will be applied every 4 or 5 hours when the child is awake, 5 times a day, in the affected area in the form of a completely covering thin layer on the skin. Necessary training will be given to the mother on how to use the medicine during the first visit. How to teach: The health and preventive measures that will be taught to mothers along with taking medicine are as follows: using linen diapers or washable cotton diapers that are washed and rinsed with soap, changing diapers or diapers regularly. As soon as the infant or child urinates, a complete explanation of the causes of diaper dermatitis including detergents, urine, diarrhea, the infant, the type of feeding and the type of diaper or the age of the infant. The number of training sessions: It is proportional to the visits of patients with their parents.Study grouping: In this study, patients are randomly divided into two groups with equal numbers. Both groups received standard treatment for diaper dermatitis including topical clotrimazole three times a day. In addition to being treated with clotrimazole ointment three times a day (every 8 hours), the treatment group is also treated with topical sucralfate 4% every 4 or 5 hours when the child wakes up 5 times a day. Diaper dermatitis severity percentage before, 3, 7 and 10 days after the intervention in case and control groups. Timepoint: First, third, seventh and tenth days. Method of measurement: Diaper Severity Score. Esfahan University of Medical Sciences Approved 2022-07-31 Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Isfahan University of Medical Sciences, No.1, Hezar jarib Blvd, Isfahan, Islamic Republic of Iran Isfahan Isfehan Iran (Islamic Republic of)