Evaluation of Topical cholestyramine versus topical zinc oxide in treatment of diaper rash
Design
A controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 70 patients. The Excel software rand function will be used for randomization.
Settings and conduct
This project will take place at Shahid Sadoughi hospital in Yazd. Patients in two groups of 35 people use cholestyramine or zinc oxide cream twice a day for 5 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diaper dermatitis in children with diarrhea; Age below 2 years. Exclusion criteria: skin or kidney diseases, birth defects, oral or genital candidiasis; using other drugs to treat diaper dermatitis; using topical antibiotics in the area of diaper dermatitis
Intervention groups
In order to investigate the effectiveness of topical cholestyramine in diaper dermatitis, 35 people in the intervention group received topical cholestyramine cream twice a day for 5 days. In the control group, 35 people received topical zinc oxide twice a day for 5 days.
Main outcome variables
Erythema intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N19
Registration date:2023-11-05, 1402/08/14
Registration timing:retrospective
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical cholestyramine and zinc oxide in the treatment of diaper dermatitis from diarrhea: a randomized, double-blind clinical trial.
Public title
The effect of topical cholestyramine in the treatment of diaper dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 24 months
Diaper dermatitis in children with diarrhea
Exclusion criteria:
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
Age
To 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.196
Health conditions studied
1
Description of health condition studied
Diaper rash
ICD-10 code
L22
ICD-10 code description
Diaper dermatitis
Primary outcomes
1
Description
Erythema severity
Timepoint
Days one, three and five after the intervention
Method of measurement
Based on scoring the severity of diaper dermatitis scale
Secondary outcomes
1
Description
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
Intervention groups
1
Description
Intervention group: 5% cholestyramine cream formulation (manufactured in Yazd Faculty of Pharmacy), use topically after each diaper change for 5 days
Category
Treatment - Drugs
2
Description
Control group: Topical zinc oxide ointment 20% (Caspian Company), applied topically after each diaper change for 5 days