Comparison of the effects of colutrimazole and terbinafine on the improvement of children's beard diaper
Design
This study was a double-blind, double-blind, clinical trial of children with diaphragm.
Settings and conduct
This study was conducted in Kashan Shahid Beheshti Hospital. After obtaining informed and written informed consent, the checklist, including demographic characteristics, lesion area, extent of the lesion per cm, the duration of the onset of dermatitis and the onset of recovery after the administration of the drug are completed.
Participants/Inclusion and exclusion criteria
Entry requirements: Children under the age of two, diagnosis of diaper rash by a pediatrician. Exit conditions: The presence of associated illnesses, such as psoriasis, zinc deficiency, drug allergy to the drugs studied
Intervention groups
Patients are divided into two groups of clotrimazole and terbinafine.
Main outcome variables
Dermestid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121017011145N21
Registration date:2019-06-11, 1398/03/21
Registration timing:retrospective
Last update:2019-06-11, 1398/03/21
Update count:0
Registration date
2019-06-11, 1398/03/21
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between effects of clotrimazole and terbinafine on diaper rash in children
Public title
Effects of clotrimazole and terbinafine on diaper rash in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children under the age of two,
Diagnosis of diaper rash by pediatrician,
Exclusion criteria:
The presence of associated illnesses such as psoriasis,
Zinc deficiency,
Drug allergy to the drugs studied,
Age
From 1 day old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: Individual
Randomization Tool: Random Number Tables
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of medical sciences, Qotbe Ravand blvd,
City
Kashan
Province
Isfehan
Postal code
8711111111
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.015
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
The extent of the diaphragmatic lesion of children's beech in cm
Timepoint
The effect of clotrimazole and terbinafine on the start of the study and follow up 7 days later
Method of measurement
Measuring questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: clotrimazole and terbinafine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Besheshti hospital
Full name of responsible person
Alireza Salimian Rizi
Street address
Kashan University of medical sciences-Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
sharif_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharif
Street address
Kashan University of Medical Sciences-Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
sharif_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Alireza Salimain Rizi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kashan University of Medical Sciences-Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
sharif_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Salimian Rizi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kashan University of Medical Sciences-Qotbe Ravandi blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
sharif_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Salimian Rizi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kashan University of Medical Sciences,Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
sharif_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information will be shared after analyzing and publishing the article.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
After publishing the results, the document can be used.
From where data/document is obtainable
Email to the responsible author
What processes are involved for a request to access data/document