Diaper Dermatitis HealingNCT06134505
Evaluation of the Efficiency of Local Application of Bee Products in the Care of Diaper Dermatitis in Infants
A study testing Use of Barrier cream group 1 in the healing of diaper dermatitis, Use of Barrier cream 2 in the healing of diaper dermatitis and Use of olive oil in the healing of diaper dermatitis in people with Diaper Dermatitis Healing, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the local application of bee products in the care of diaper dermatitis in infants. 1. H1: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than… 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 Healing
- What is being tested?
- Use of Barrier cream group 1 in the healing of diaper dermatitis, Use of Barrier cream 2 in the healing of diaper dermatitis and Use of olive oil in the healing of diaper dermatitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2022to 8 Nov 2023
- 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
- Infants aged 1-6 months registered at Family Health Centers No. 1, No. 2 and No. 3,
- Infants aged 1-6 months admitted to Kumluca State Hospital's Pediatric Outpatient Clinic,
- Infants with grade one diaper dermatitis according to the Uncomplicated Diaper Dermatitis in Infants Severity Rating Scale,
- Breastfed babies,
- Babies without antibiotics,
- Families who do not regularly use protective barrier cream/oil for diaper dermatitis care,
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- Babies who have not started supplementary food,
- Babies with no other dermatologic or allergic skin conditions,
- Families who agreed to participate in the study were included.
Who cannot join
- Babies who are not registered to the Family Health Centers where the research was conducted,
- Newborns and babies older than 6 months who apply to the Pediatric Outpatient Clinic of Kumluca State Hospital,
- Babies who do not have first degree diaper dermatitis according to the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants,
- Babies fed with breast milk + formula or only formula,
- Babies using antibiotics,
- Families who regularly use protective barrier cream/oil in diaper dermatitis care,
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- Babies who switch to solid food,
- Babies with dermatological or other allergic skin problems,
- Babies using antimycotic drugs (Ampotericin etc.),
- Babies who use a bladder for a long time,
- Babies with urinary incontinence due to diseases such as meningomyolocele and cerebral palsy,
- Families who did not agree to participate in the research were not included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Provincial Directorate of Health
Antalya, Kumluca/Antalya, 07000
About this study
The aim of this study was to evaluate the local application of bee products in the care of diaper dermatitis in infants.
- H1: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than barrier cream 2 containing zinc oxide.
- H2: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than olive oil.
- H3: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, compared to babies who use barrier cream 2, which contains zinc oxide.
- H4: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, than babies who use olive oil.
Read the detailed description
Diaper dermatitis is one of the most common dermatological problems of infancy. Diaper dermatitis constitute from approximately 25% of visits to primary health care services for dermatological complaints in the first year of life. The ABCDE rule is based on the prevention of diaper dermatitis. According to ABCDE rule; airing the bottom of babies with diaper dermatitis, changing diapers hourly in the newborn period, every 3-4 hours in infancy, cleaning using warm water or wet wipes sucked with water, applying barrier creams in a thin layer after cleaning the area, and protecting from diaper dermatitis and providing diaper hygiene. Families should be educated on the right skin care practices. This thesis study was conducted in a randomized control experimental design in order to investigate the effect of olive oil, 40% zinc oxide, propolis, royal jelly, perga and plant oil mixture on the healing process in the care of 1-6 months old infants with first degree diaper dermatitis who applied to the Family Health Center/ Child Outpatient Clinic. The population of the study will be 1-6 month old babies with first degree diaper dermatitis who are registered to Family Health Centers in Antalya's Kumluca district and applied to the pediatric outpatient clinic of Kumluca State Hospital. The sample of the study was consisted of 93 infants (Olive oil: 31, propolis, beeswax, queen bee larva and plant oil mixture: 31, 40% zinc oxide cream: 31) registered to the Family Health Center and and applied to Kumluca State Hospital between January 2022 and December 2023, aged 1-6 months and meeting the sample selection criteria. The data were collected using the "Parent-Infant Descriptive Information Form", "Observation Forms", and "Assessing the Severity of Uncomplicated Diaper Dermatitis" in Infants Scale in Infants, after obtaining the permission of the ethics committee and institution of the research. The data was evaluated using the SPSS 23 package program.
- Conditions
- Diaper Dermatitis Healing
- Being tested
- Use of Barrier cream group 1 in the healing of diaper dermatitis, Use of Barrier cream 2 in the healing of diaper dermatitis, Use of olive oil in the healing of diaper dermatitis
- Keywords
- diaper dermatitis, healing, bee products, care
- 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 Barrier cream group 1 in the healing of diaper dermatitisProcedure or surgery
In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that Barrier cream 1 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.
Use of Barrier cream 2 in the healing of diaper dermatitisProcedure or surgery
In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that barrier cream 2 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.
Use of olive oil in the healing of diaper dermatitisProcedure or surgery
In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that olive oil would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental Group1 | Experimental | Barrier cream group 1 consists of a mixture of propolis, beeswax, queen bee larva and plant oil Receives: Procedure: Use of Barrier cream group 1 in the healing of diaper dermatitis |
| Experimental: Experimental Group2 | Experimental | Olive oil group Receives: Procedure: Use of olive oil in the healing of diaper dermatitis |
| Control Group | Active comparator | Barrier cream group 2 consists of zinc oxide Receives: Procedure: Use of Barrier cream 2 in the healing of diaper dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants
The score to be received from each item of the scale varies between "0-6". The highest and lowest scores that can be obtained from the items are 0-3 points in the "Severity of Erythema or Irritation" item, 0-1 point in the "Extent of Diaper Dermatitis" item, 0-1 point in the "Papules and Pustules" item, and 0-1 point in the "Light Skin" item. It is between 0-1 points. Low total scores from the scale indicate that the severity of diaper dermatitis is low, and high scores indicate that the severity of diaper dermatitis is high.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Dec 2022
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper Dermatitis HealingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur KAHRİMAN, Karadeniz Technical University
- Investigators
- Ilknur Kahriman, Assoc. Prof., Study director, Karadeniz Technical UniversityBahar Aksoy, MAster, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134505
- Sponsor's protocol ID
- İlknurKahriman
- Status last verified
- Jan 2024
- First submitted
- 7 Nov 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Local Application of Bee Products in the Care of Diaper Dermatitis in Infants
- ClinicalTrials.gov ID
- NCT06134505
- Acronym / sponsor ID
- İlknurKahriman
- Conditions
- Diaper Dermatitis Healing
- Keywords
- diaper dermatitis, healing, bee products, care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 24 Dec 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 18 Nov 2023 (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.
The aim of this study was to evaluate the local application of bee products in the care of diaper dermatitis in infants.
- H1: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than barrier cream 2 containing zinc oxide.
- H2: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than olive oil.
- H3: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, compared to babies who use barrier cream 2, which contains zinc oxide.
- H4: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, than babies who use olive oil.
Detailed description
Diaper dermatitis is one of the most common dermatological problems of infancy. Diaper dermatitis constitute from approximately 25% of visits to primary health care services for dermatological complaints in the first year of life. The ABCDE rule is based on the prevention of diaper dermatitis. According to ABCDE rule; airing the bottom of babies with diaper dermatitis, changing diapers hourly in the newborn period, every 3-4 hours in infancy, cleaning using warm water or wet wipes sucked with water, applying barrier creams in a thin layer after cleaning the area, and protecting from diaper dermatitis and providing diaper hygiene. Families should be educated on the right skin care practices. This thesis study was conducted in a randomized control experimental design in order to investigate the effect of olive oil, 40% zinc oxide, propolis, royal jelly, perga and plant oil mixture on the healing process in the care of 1-6 months old infants with first degree diaper dermatitis who applied to the Family Health Center/ Child Outpatient Clinic. The population of the study will be 1-6 month old babies with first degree diaper dermatitis who are registered to Family Health Centers in Antalya's Kumluca district and applied to the pediatric outpatient clinic of Kumluca State Hospital. The sample of the study was consisted of 93 infants (Olive oil: 31, propolis, beeswax, queen bee larva and plant oil mixture: 31, 40% zinc oxide cream: 31) registered to the Family Health Center and and applied to Kumluca State Hospital between January 2022 and December 2023, aged 1-6 months and meeting the sample selection criteria. The data were collected using the "Parent-Infant Descriptive Information Form", "Observation Forms", and "Assessing the Severity of Uncomplicated Diaper Dermatitis" in Infants Scale in Infants, after obtaining the permission of the ethics committee and institution of the research. The data was evaluated using the SPSS 23 package program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental Group1 | Experimental | Procedure: Use of Barrier cream group 1 in the healing of diaper dermatitisBarrier cream group 1 consists of a mixture of propolis, beeswax, queen bee larva and plant oil |
| Experimental: Experimental Group2 | Experimental | Procedure: Use of olive oil in the healing of diaper dermatitisOlive oil group |
| Control Group | Active comparator | Procedure: Use of Barrier cream 2 in the healing of diaper dermatitisBarrier cream group 2 consists of zinc oxide |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Infants aged 1-6 months registered at Family Health Centers No. 1, No. 2 and No. 3,
- Infants aged 1-6 months admitted to Kumluca State Hospital's Pediatric Outpatient Clinic,
- Infants with grade one diaper dermatitis according to the Uncomplicated Diaper Dermatitis in Infants Severity Rating Scale,
- Breastfed babies,
- Babies without antibiotics,
Key exclusion criteria (12 listed)
- Babies who are not registered to the Family Health Centers where the research was conducted,
- Newborns and babies older than 6 months who apply to the Pediatric Outpatient Clinic of Kumluca State Hospital,
- Babies who do not have first degree diaper dermatitis according to the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants,
- Babies fed with breast milk + formula or only formula,
- Babies using antibiotics,
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 Barrier cream group 1 in the healing of diaper dermatitisIn this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that Barrier cream 1 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved. | Procedure or surgery | Experimental: Experimental Group1 |
| Use of Barrier cream 2 in the healing of diaper dermatitisIn this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that barrier cream 2 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved. | Procedure or surgery | Control Group |
| Use of olive oil in the healing of diaper dermatitisIn this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that olive oil would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved. | Procedure or surgery | Experimental: Experimental Group2 |
Primary outcome
Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants
Time frame: 5 minutes
The score to be received from each item of the scale varies between "0-6". The highest and lowest scores that can be obtained from the items are 0-3 points in the "Severity of Erythema or Irritation" item, 0-1 point in the "Extent of Diaper Dermatitis" item, 0-1 point in the "Papules and Pustules" item, and 0-1 point in the "Light Skin" item. It is between 0-1 points. Low total scores from the scale indicate that the severity of diaper dermatitis is low, and high scores indicate that the severity of diaper dermatitis is high.
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 17 Jan 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
Ilknur Kahriman, Assoc. Prof. study director
Karadeniz Technical University
Bahar Aksoy, MAster principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Barrier cream group 1 in the healing of diaper dermatitis, Use of Barrier cream 2 in the healing of diaper dermatitis and Use of olive oil in the healing of diaper dermatitis in people with Diaper Dermatitis Healing, run by Karadeniz Technical University at 1 site 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 9 inclusion and 12 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants (time frame: 5 minutes). 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 17 Jan 2024.