Comparison of the effect of dexpanthenol cream with zinc oxide ointment in the treatment of children's diaper rash
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 126 patients. It was drawn for randomization.
Settings and conduct
The study will be conducted as a clinical trial in the Qom Children's Center. 186 children under one year old will be selected and divided into two groups of 93 people. The first group will receive dexpantol ointment and the second group will receive zinc oxide ointment. Both ointments are used after every time of washing the child's feet. The image of the rash is compared with the scale image on days 1, 3, and 7.
Participants/Inclusion and exclusion criteria
Criteria for entering patients:
Children under 1 year old with urinary burns without underlying disease
Patient discharge criteria:
Children over 1 year old with immune deficiencies and underlying diseases such as diabetes, metabolic disorders and malabsorption syndromes
Having satellite lesions caused by Candida in the groin
Intervention groups
186 children under one year of age with urinary incontinence will be selected and divided into two groups of 93 people, the first group using dexpantol ointment and the second group using zinc oxide.
Main outcome variables
the rate of reduction in the number of rashes; reducing the burning of the child's feet; Reducing the level of redness of the child's feet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230606058394N2
Registration date:2024-03-06, 1402/12/16
Registration timing:registered_while_recruiting
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
seyede zeinab modarresy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3162 5224
Email address
z.modarresy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-30, 1402/11/10
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexpanthenol cream with zinc oxide ointment in the treatment of diaper rash in children
Public title
The effect of dexpanthenol on urinary burns of children's feet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age under 1 year
Having diaper rash
Exclusion criteria:
Having an immune deficiency
Having metabolic disorders
Having malabsorption
having diabetes
Having satellite lesions caused by Candida in the groin
Reluctance to cooperate
Age
From 1 month old to 12 months old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
186
More than 1 sample in each individual
Number of samples in each individual:
3
On each of the 1st, 3rd, and 7th days, we calculate the incidence and treatment of the disease by considering the photo scale.
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, groups are written in the form of group A, B. Then there will be a draw between the two groups, which will be the intervention group and which will be the control group. In the second step, the numbers of two cards written on one A and the other B and completely closed and not visible are thrown into a container. In the third stage, after obtaining consent from the patients and agreeing to participate in the study, they are asked to choose one of the two cards in the container in order to determine the treatment group. Then he takes a card from inside the container and hands it to the nurse, the nurse notes the treatment group and the ointment is prescribed for the people who belong to the intervention group.
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 Qom Medical Sciences
Street address
Qom. Pediatric Clinical Research Development Unit. Hazrat Masoumeh (S) Hospital
City
ghoum
Province
Ghoum
Postal code
3713649373
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.MUQ.REC.1402.211
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 frequency of diaper rash in the intervention and control groups
Timepoint
1, 3 and 7 days after using dexpanthenol and zinc oxide ointment in two groups
Method of measurement
On each of the 1st, 3rd, and 7th days, we calculate the incidence and treatment of this disease by considering the photo as a scale. The ointment is explained to the mother and a printout of the scale image is given to the mother, and she is contacted at the appointed time and the examination is done by announcing the mother's opinion according to the mentioned scale.
Secondary outcomes
1
Description
Duration of diaper rash treatment in the dexpanthenol cream study group compared to the zinc oxide group
Timepoint
Day 3 and 7 after using the ointment
Method of measurement
Based on the picture of the treatment progress scale
2
Description
Scars left from wounds and inflammations after treatment are less in which cream
Timepoint
Day 3 and 7 after using the ointment
Method of measurement
Based on the picture of the treatment progress scale
Intervention groups
1
Description
Intervention group: Children under one year of age who will receive dexpanthenol ointment after developing diaper rash. Dexpanthenol ointment (each 100 grams contains 5 grams of dexpanthenol) analog of vitamin B complex. Produced by Caspian Tamin Company. Treatment of itching, wounds, insect bites, poison ivy, poison oak, stimulation of areas of the baby's skin that are in contact with urine, scratches, mild eczema, bedsores, dry wastes. Dexpanthenol ointment should be used for the first time after every 6th bath of the baby, in the area of the rash. Three days after the treatment in person and seven days after delivery by telephone, follow-up of the newborns will be done in terms of the extent of redness, the number of pimples, etc. based on a visual scale.
Category
Treatment - Drugs
2
Description
Control group: children with diaper rash who, in addition to routine maintenance treatment, 25% Zinc Oxide Mediform ointment (a mineral substance that is used to treat minor skin irritations such as burns, cuts, and minor scratches and to treat and prevent diaper rashes and rashes) ) they receive. Three days after the treatment in person and seven days after the treatment by phone, the follow-up of the babies will be done in terms of the extent of redness, the number of pimples, etc. based on a visual scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Masoumeh educational and therapeutic center
Full name of responsible person
Seyyed Zainab Madrresy
Street address
Qom . Imam street . Hazrat Masoumeh educational and therapeutic center
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
z.modarresy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyyed Zainab Madrasi
Street address
Qom, Safashehr St., Shahid Lotfi Niaser Alley, Qom University of Medical Sciences, Vice President of Research and Technology
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
z.modarresy@gmail.com
Web page address
https://pediatriccrdc.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Seyede Zeinab Modarresy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Clinical Research Development Unit, Hazrat Masoumeh Hospital. Zainuddin Square. Qom, Iran.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Fax
Email
Z.modarresy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyyed Zainab Madrasi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam St. Children's Hospital
City
ghoum
Province
Ghoum
Postal code
3713649373
Phone
009831625224
Email
z.modarresy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyede zeinab Modarresy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Clinical Research Development Unit, Hazrat Masoumeh Hospital. Zainuddin Square. Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Fax
Email
z.modarresy@gmail.com
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Checklist to check the desired information to compare two groups receiving two drugs. It can be provided
When the data will become available and for how long
The data presentation time is 6 months after collection at the end of 1403
To whom data/document is available
All researchers
Under which criteria data/document could be used
No condition
From where data/document is obtainable
Refer to the Children's Clinical Research Development Unit
What processes are involved for a request to access data/document