Determining the effect of 4% topical sucralfate in the treatment of erosive diaper dermatitis with candidiasis
Design
This study is a double-blind randomized clinical trial study (the patient and the examiner are blinded to the type of treatment) in which outpatients who visited the pediatric dermatology clinic of Imam Hossein (AS) Hospital in Isfahan between July 1401 and July 1402 or have been hospitalized in this center, they will be included in the study randomly in two groups. Written consent will be obtained from the parents of the children before entering the study and after explaining the study method.
Settings and conduct
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. The place of study is Imam Hossein Children's Hospital, Isfahan.
Participants/Inclusion and exclusion criteria
Children less than two years and more than 30 days
Intervention groups
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.
Main outcome variables
Diaper dermatitis severity percentage before, 3, 7 and 10 days after the intervention in case and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221018056230N1
Registration date:2022-11-26, 1401/09/05
Registration timing:registered_while_recruiting
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Seyedh Zahra Moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4429 9733
Email address
szm.gp68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 4% Topical Sucralfate in Erosive Candidial Diaper Dermatitis
Public title
Investigation of 4% topical sucralfate in the topical treatment of children with diaper dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children less than 2 years after infancy with a new clinical diagnosis of Candidiasis Rosacea due to diaper movement
Exclusion criteria:
Age
From 30 days old to 2 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
4
First, third, seventh, tenth days
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, No.1, Hezar jarib Blvd, Isfahan, Islamic Republic of Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.MUI.MED.REC.1401.179
Health conditions studied
1
Description of health condition studied
Erosive Candidial Diaper Dermatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Isfahan
Full name of responsible person
Parisa Iravani
Street address
Imam Hosein Hospital, No.1, Imam khomaini st,
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Iravaniparisa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Asgari
Street address
Hezar jarib, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Moosavi
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Unit. 1, No.8, Alvan 14 Alley, Ebrahimi St, Marzdaran Blva
City
Tehran
Province
Tehran
Postal code
1461886681
Phone
+98 21 4429 9733
Email
szm.gp68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Moosavi
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Unit. 1, No.8, Alvan 14 Alley, Ebrahimi St, Marzdaran Blva
City
Tehran
Province
Tehran
Postal code
1463735641
Phone
+98 21 4429 9733
Email
szm.gp68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Moosavi
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Unit. 1, No.8, Alvan 14 Alley, Ebrahimi St, Marzdaran Blva
City
Tehran
Province
Tehran
Postal code
1463735641
Phone
+98 21 4429 9733
Email
szm.gp68@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available