Diaper DermatitisdermatitNCT06699303
Effect of Breast Milk on Diaper Dermatitis in Infants
A study of Diaper Dermatitis, run by Sakarya University at 2 sites in Turkey (Türkiye).
Trial summary
Diaper dermatitis, one of infants' most common health problems, can be treated with various methods. One of these methods is breast milk. Studies show that breast milk is a non-harmful, accessible and effective product in the healing of dermatitis. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Diaper Dermatitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2023to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies fed with breast milk,
- Healthy babies aged 0-6 months,
- Babies who do not have diarrhea or thrush at the time of application,
- Fungus, eczema, allergic disease, etc.Babies without a history of skin disease,
- Babies who do not use antimycotic drugs (Ampotericin etc.), antibiotics and steriods ---before and during the application,
- Babies who do not apply medication or other materials (barrier creams, powder and other medications) to the dermatitis area.
Who cannot join
- Babies who are not breastfed
- Those who did not agree to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sakarya Training and Research Hospital
Sakarya, Adapzarı, 54100
Sakarya Üniversitesi
Sakarya, Adapzarı, 54100
About this study
Official title: Study of the Effect of Breast Milk and Hamamelis Virginiana (Potency12MG/100G) on the Healing of Diaper Dermatitis in Infants
Diaper dermatitis, one of infants' most common health problems, can be treated with various methods. One of these methods is breast milk. Studies show that breast milk is a non-harmful, accessible and effective product in the healing of dermatitis. This study was planned to be a randomized, controlled, and single-blinded study to evaluate the effect of breast milk and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g on the healing process in 0-12-month-old infants with diaper dermatitis. The population of the study consisted of 0-12 months old infants with diaper dermatitis who applied to the Pediatrics Outpatient Clinic of X Hospital. Since not all infants with diaper dermatitis complaints were examined, the number of the population cannot be known. The sample size was calculated as 26 for each group and 52 in total . 30 infants were planned to be included in each group. The licensed IBM SPSS 22.0 (Statistical Package for the Social Sciences) package program will be used for statistical data analysis. Standard deviation, number and percentage will be used in data analysis. Man Whitney U test and Fisher exact test (repeated measures) will be used to evaluate whether there is a difference between independent groups. For the significance level of the data, 0.05 will be used.
Read the detailed description
Diaper dermatitis, one of the most common health problems in infants, can be treated with various methods (Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017). One of these methods is breast milk. Breast milk has strong immunologic properties that protect infants from respiratory diseases, middle ear infections and gastrointestinal system diseases. It also has protective effects against diabetes mellitus, obesity, hyperlipidemia, hypertension, cardiovascular diseases, autoimmunity and asthma. Because of these positive properties, breast milk has lifelong positive effects. In recent years, studies on the effect of breast milk in the treatment of dermatitis have been increasing (Kasrae, Farahani, Yousefi, 2015, Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017, Bener et al., 2007). In a study conducted by Gozen et al. using breast milk and barrier cream, barrier cream was found to be more effective than breast milk, especially in the treatment of moderate and severe dermatitis (Gozen et al., 2014). Farahani et al. applied 1% hydrocortisol and breast milk for 7 days in a randomized controlled study on diaper dermatitis. In this study, improvement was found to be similar on the 3rd and 7th days of treatment and it was concluded that breast milk was safe and effective (Farahani, Ghobadzadeh, Yousefi, 2013) Seifi et al. found a statistically significant difference between the groups in favor of breast milk in terms of skin rash score on the first and third days of the application in their study using breast milk in diaper rash care (p=0.013, p=0.005, respectively). This difference was even more significant on the fifth day (p=0.004, p=0.001) (Seifi et al., 2017). Studies show that breast milk is a non-harmful, free and effective product for the healing of dermatitis.
This study was planned to be a randomized, controlled, and single-blinded study to evaluate the effect of breast milk and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g on the healing process in 0-12-month-old infants with diaper dermatitis. The population of the study consisted of 0-12 months old infants with diaper dermatitis who applied to the Pediatrics Outpatient Clinic . Since not all infants with diaper dermatitis complaints were examined, the number of the population cannot be known. The sample size was calculated as 26 for each group and 52 in total with the "A priori. 30 infants were planned to be included in each group. The licensed IBM SPSS 22.0 (Statistical Package for the Social Sciences) package program will be used for statistical data analysis. Standard deviation, number and percentage will be used in data analysis. Man Whitney U test and Fisher exact test (repeated measures) will be used to evaluate whether there is a difference between independent groups. For the significance level of the data, 0.05 will be used.
- Conditions
- Diaper Dermatitis
- Being tested
- Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis care
- Keywords
- diaper dermatitis, mother's milk, hamamelı̇s vı̇rgı̇nı̇nana
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis careOther
Also called Administration of mother's milk for infants in the experimental group in the care of diaper dermatitis
In diaper dermatitis care, it was planned to use their mothers' milk for the babies in the experimental group and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g for the babies in the control group. The reason why diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g is preferred is that it is the most frequently used cream in cases of uncomplicated diaper dermatitis. The mothers of the babies in the control group will be asked to wash and dry the baby's diaper with soap and water during each diaper change and then apply diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g. Mothers will be asked to record any new signs and symptoms that develop during the treatment and to inform the investigators will be asked to provide information. Positive and negative effects of treatment will also be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies | Experimental | In the study, a data collection form consisting of 13 questions regarding the sociodemographic characteristics of 0-12 month old babies and the "Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies, developed by Buckley et al. in 2016 and whose Turkish validity and reliability studies were conducted by Keskin, will be used. Receives: Other: Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis care |
What is being measured
The primary outcome is the main question the study is designed to answer.
It will be evaluated whether there is a difference between breast milk and dermatitis cream in terms of healing diaper dermatitis in babies aged 0-12 months.
Data will be collected using the baby identification form and the Infant Uncomplicated Diaper Dermatitis Severity Rating Scale (UCDAS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 May 2023
- Primary completion18 Jan 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- It was planned as a randomized controlled and single blinded study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Döndü 1 Sevimli Güler, PhD, Principal investigator, Sakarya Training and Research HospitalZekiye 4 Turan, PhD, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699303
- Sponsor's protocol ID
- E-16214662-050.01.04-220310-04
- Acronym
- dermatit
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study findings have not yet been published.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Breast Milk and Hamamelis Virginiana (Potency12MG/100G) on the Healing of Diaper Dermatitis in Infants
- ClinicalTrials.gov ID
- NCT06699303
- Acronym / sponsor ID
- dermatit / E-16214662-050.01.04-220310-04
- Conditions
- Diaper Dermatitis
- Keywords
- diaper dermatitis, mother's milk, hamamelı̇s vı̇rgı̇nı̇nana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diaper dermatitis, one of infants' most common health problems, can be treated with various methods. One of these methods is breast milk. Studies show that breast milk is a non-harmful, accessible and effective product in the healing of dermatitis. This study was planned to be a randomized, controlled, and single-blinded study to evaluate the effect of breast milk and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g on the healing process in 0-12-month-old infants with diaper dermatitis. The population of the study consisted of 0-12 months old infants with diaper dermatitis who applied to the Pediatrics Outpatient Clinic of X Hospital. Since not all infants with diaper dermatitis complaints were examined, the number of the population cannot be known. The sample size was calculated as 26 for each group and 52 in total . 30 infants were planned to be included in each group. The licensed IBM SPSS 22.0 (Statistical Package for the Social Sciences) package program will be used for statistical data analysis. Standard deviation, number and percentage will be used in data analysis. Man Whitney U test and Fisher exact test (repeated measures) will be used to evaluate whether there is a difference between independent groups. For the significance level of the data, 0.05 will be used.
Detailed description
Diaper dermatitis, one of the most common health problems in infants, can be treated with various methods (Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017). One of these methods is breast milk. Breast milk has strong immunologic properties that protect infants from respiratory diseases, middle ear infections and gastrointestinal system diseases. It also has protective effects against diabetes mellitus, obesity, hyperlipidemia, hypertension, cardiovascular diseases, autoimmunity and asthma. Because of these positive properties, breast milk has lifelong positive effects. In recent years, studies on the effect of breast milk in the treatment of dermatitis have been increasing (Kasrae, Farahani, Yousefi, 2015, Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017, Bener et al., 2007). In a study conducted by Gozen et al. using breast milk and barrier cream, barrier cream was found to be more effective than breast milk, especially in the treatment of moderate and severe dermatitis (Gozen et al., 2014). Farahani et al. applied 1% hydrocortisol and breast milk for 7 days in a randomized controlled study on diaper dermatitis. In this study, improvement was found to be similar on the 3rd and 7th days of treatment and it was concluded that breast milk was safe and effective (Farahani, Ghobadzadeh, Yousefi, 2013) Seifi et al. found a statistically significant difference between the groups in favor of breast milk in terms of skin rash score on the first and third days of the application in their study using breast milk in diaper rash care (p=0.013, p=0.005, respectively). This difference was even more significant on the fifth day (p=0.004, p=0.001) (Seifi et al., 2017). Studies show that breast milk is a non-harmful, free and effective product for the healing of dermatitis.
This study was planned to be a randomized, controlled, and single-blinded study to evaluate the effect of breast milk and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g on the healing process in 0-12-month-old infants with diaper dermatitis. The population of the study consisted of 0-12 months old infants with diaper dermatitis who applied to the Pediatrics Outpatient Clinic . Since not all infants with diaper dermatitis complaints were examined, the number of the population cannot be known. The sample size was calculated as 26 for each group and 52 in total with the "A priori. 30 infants were planned to be included in each group. The licensed IBM SPSS 22.0 (Statistical Package for the Social Sciences) package program will be used for statistical data analysis. Standard deviation, number and percentage will be used in data analysis. Man Whitney U test and Fisher exact test (repeated measures) will be used to evaluate whether there is a difference between independent groups. For the significance level of the data, 0.05 will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It was planned as a randomized controlled and single blinded study.
| Arm | Type | Receives |
|---|---|---|
| Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies | Experimental | Other: Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis careIn the study, a data collection form consisting of 13 questions regarding the sociodemographic characteristics of 0-12 month old babies and the "Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies, developed by Buckley et al. in 2016 and whose Turkish validity and reliability studies were conducted by Keskin, will be used. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Babies fed with breast milk,
- Healthy babies aged 0-6 months,
- Babies who do not have diarrhea or thrush at the time of application,
- Fungus, eczema, allergic disease, etc.Babies without a history of skin disease,
- Babies who do not use antimycotic drugs (Ampotericin etc.), antibiotics and steriods ---before and during the application,
Key exclusion criteria (2 listed)
- Babies who are not breastfed
- Those who did not agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis careAlso: Administration of mother's milk for infants in the experimental group in the care of diaper dermatitisIn diaper dermatitis care, it was planned to use their mothers' milk for the babies in the experimental group and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g for the babies in the control group. The reason why diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g is preferred is that it is the most frequently used cream in cases of uncomplicated diaper dermatitis. The mothers of the babies in the control group will be asked to wash and dry the baby's diaper with soap and water during each diaper change and then apply diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g. Mothers will be asked to record any new signs and symptoms that develop during the treatment and to inform the investigators will be asked to provide information. Positive and negative effects of treatment will also be recorded. | Other | Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies |
Primary outcome
It will be evaluated whether there is a difference between breast milk and dermatitis cream in terms of healing diaper dermatitis in babies aged 0-12 months.
Time frame: 6 months
Data will be collected using the baby identification form and the Infant Uncomplicated Diaper Dermatitis Severity Rating Scale (UCDAS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. Our study findings have not yet been published.
Related trials for Diaper Dermatitis
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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Döndü 1 Sevimli Güler, PhD principal investigator
Sakarya Training and Research Hospital
Zekiye 4 Turan, PhD study director
Sakarya University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diaper Dermatitis, run by Sakarya University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It will be evaluated whether there is a difference between breast milk and dermatitis cream in terms of healing diaper dermatitis in babies aged 0-12 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.