Diaper DermatitisNCT06800352
The Effect of Olive Oil and Centaury Oil on Rash
A study of Diaper Dermatitis, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Diaper dermatitis is a preventable health problem. No study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. This study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Diaper Dermatitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 Jun 2025
- 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 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The baby has mild diaper dermatitis according to the diaper dermatitis severity rating scale
- The baby receives antibiotic treatment
- The baby gets additional food
- The baby is between 6-18 months
Who cannot join
- Infants with moderate or severe diaper dermatitis according to the diaper dermatitis severity rating scale
- Babies with open wounds on the perineum,
- Babies with any skin disease
- Babies who use barrier creams or special oils in routine care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Olive Oil and Centaury Oil in the Management of Diaper Dermatitis
Diaper dermatitis is a preventable health problem. No study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. This study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis.
Read the detailed description
Diaper dermatitis is estimated to have an incidence of between 7% and 35%, although the prevalence cannot be determined precisely because it is not usually seen as a disease by parents and most patients are treated at home. Prevention of diaper dermatitis should be the main approach in treatment and care. Once it occurs, the aim of treatment is to accelerate the healing of the damaged area and prevent its spread. In the prevention and treatment of diaper dermatitis, practices such as ventilating the baby's diaper, changing the diaper frequently, keeping the area dry, cleaning with appropriate methods, using barrier creams and not tying the diaper tightly have been reported to be beneficial.
In the literature, studies using methods such as water, herbal cream (chamomile cream, calendula cream, aloe vera cream), barrier cream (zinc oxide) and herbal mixture (honey, beeswax, olive oil) were found in the treatment of infants with mild to moderate diaper dermatitis. It has been stated that the rates of diaper dermatitis will continue to increase if parents are not given adequate information about appropriate care and which products are beneficial or even harmful. In conclusion, diaper dermatitis is a preventable health problem. No study evaluating the efficacy of olive oil and centaury oil in diaper dermatitis was found in the literature. This study will be conducted to examine the effect of olive oil and centaury oil in the management of diaper dermatitis.
- Conditions
- Diaper Dermatitis
- Being tested
- Control
- Keywords
- olive oil, centaury oil, diaper dermatitis
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
The degree of diaper dermatitis of the babies will be evaluated before and after the procedure (72 hours after the first procedure) by using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Babies (UNDDCS)'. Mothers will be asked to diaper their babies with cotton wool soaked with clear water.
| Study group | Role | What they receive |
|---|---|---|
| Olive Oil Application | Experimental | The degree of diaper dermatitis will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply olive oil to the perineum four times a day, 1 cc each time. Receives: Other: Control |
| Centaury Oil Application | Experimental | The degree of diaper dermatitis of the infants will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply centaury oil to the perineum four times a day, 1 cc each time. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measures
The outcome measures for the sociodemographic data of the study will be collected by using the 'Introductory Information Form', which includes questions about the infant's identifying characteristics such as gender, age, height, weight and diaper care.
The other outcome measure to be used in the study is the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants' which will be used to rate the severity of diaper dermatitis in infants.
Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants: The lowest score that can be obtained from the scale consisting of a total of four items is zero and the highest score is six. The minimum and maximum scores that can be obtained from each item are 0-3 points for the severity of erythema or irritation item, 0-1 point for the degree of diaper dermatitis item, 0-1 point for the papules and pustules item and 0-1 point for the open skin item. As the score on the scale increases, the degree of diaper dermatitis also increases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomisation method will be used in this study. Using the online programme (http://www.randomizer.org), a random list of sets assigning infants to groups will be created. The infants who will constitute the sample of the study will be divided into 20 sets with 3 people in each set and sets will be formed by assigning numbers from 1 to 3 to each set. When the sets are obtained, the numbers from 1 to 3 will be written on small papers and group assignments will be made by lot method. In this way, the number of babies included in the groups and the probability of each baby to be included in the study groups will be equalised.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HASRET YAĞMUR SEVİNÇ AKIN, Harran University
- Investigators
- H YAĞMUR SEVİNÇ AKIN, Assistant Professor, Study director, Harran UniversityMAKSUDE YILDIRIM, Assistant Professor, Principal investigator, Adiyaman UniversityBARIŞ AKIN, Specialist nurse, Principal investigator, Mardin Training and Research HospitalNESRİN ŞEN CELASİN, Assoc. Professor, Principal investigator, Manisa Celal Bayar UniversityZÜLEYHA GÜRDAP, RESEARCH ASSISTANT, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800352
- Sponsor's protocol ID
- HRU-VSYO-HYSA-2024/139
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Olive Oil and Centaury Oil in the Management of Diaper Dermatitis
- ClinicalTrials.gov ID
- NCT06800352
- Acronym / sponsor ID
- HRU-VSYO-HYSA-2024/139
- Conditions
- Diaper Dermatitis
- Keywords
- olive oil, centaury oil, diaper dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Jan 2025 (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 is a preventable health problem. No study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. This study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis.
Detailed description
Diaper dermatitis is estimated to have an incidence of between 7% and 35%, although the prevalence cannot be determined precisely because it is not usually seen as a disease by parents and most patients are treated at home. Prevention of diaper dermatitis should be the main approach in treatment and care. Once it occurs, the aim of treatment is to accelerate the healing of the damaged area and prevent its spread. In the prevention and treatment of diaper dermatitis, practices such as ventilating the baby's diaper, changing the diaper frequently, keeping the area dry, cleaning with appropriate methods, using barrier creams and not tying the diaper tightly have been reported to be beneficial.
In the literature, studies using methods such as water, herbal cream (chamomile cream, calendula cream, aloe vera cream), barrier cream (zinc oxide) and herbal mixture (honey, beeswax, olive oil) were found in the treatment of infants with mild to moderate diaper dermatitis. It has been stated that the rates of diaper dermatitis will continue to increase if parents are not given adequate information about appropriate care and which products are beneficial or even harmful. In conclusion, diaper dermatitis is a preventable health problem. No study evaluating the efficacy of olive oil and centaury oil in diaper dermatitis was found in the literature. This study will be conducted to examine the effect of olive oil and centaury oil in the management of diaper dermatitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomisation method will be used in this study. Using the online programme (http://www.randomizer.org), a random list of sets assigning infants to groups will be created. The infants who will constitute the sample of the study will be divided into 20 sets with 3 people in each set and sets will be formed by assigning numbers from 1 to 3 to each set. When the sets are obtained, the numbers from 1 to 3 will be written on small papers and group assignments will be made by lot method. In this way, the number of babies included in the groups and the probability of each baby to be included in the study groups will be equalised.
| Arm | Type | Receives |
|---|---|---|
| Olive Oil Application | Experimental | Other: ControlThe degree of diaper dermatitis will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply olive oil to the perineum four times a day, 1 cc each time. |
| Centaury Oil Application | Experimental | Other: ControlThe degree of diaper dermatitis of the infants will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply centaury oil to the perineum four times a day, 1 cc each time. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The baby has mild diaper dermatitis according to the diaper dermatitis severity rating scale
- The baby receives antibiotic treatment
- The baby gets additional food
- The baby is between 6-18 months
Key exclusion criteria (4 listed)
- Infants with moderate or severe diaper dermatitis according to the diaper dermatitis severity rating scale
- Babies with open wounds on the perineum,
- Babies with any skin disease
- Babies who use barrier creams or special oils in routine care
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 |
|---|---|---|
| ControlThe degree of diaper dermatitis of the babies will be evaluated before and after the procedure (72 hours after the first procedure) by using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Babies (UNDDCS)'. Mothers will be asked to diaper their babies with cotton wool soaked with clear water. | Other | Centaury Oil Application, Olive Oil Application |
Primary outcome
Outcome Measures
Time frame: 1 year
The outcome measures for the sociodemographic data of the study will be collected by using the 'Introductory Information Form', which includes questions about the infant's identifying characteristics such as gender, age, height, weight and diaper care. The other outcome measure to be used in the study is the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants' which will be used to rate the severity of diaper dermatitis in infants. Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants: The lowest score that can be obtained from the scale consisting of a total of four items is zero and the highest score is six. The minimum and maximum scores that can be obtained from each item are 0-3 points for the severity of erythema or irritation item, 0-1 point for the degree of diaper dermatitis item, 0-1 point for the papules and pustules item and 0-1 point for the open skin item. As the score on the scale increases, the degree of diaper dermatitis also increases
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 30 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis
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.
H YAĞMUR SEVİNÇ AKIN, Assistant Professor study director
Harran University
MAKSUDE YILDIRIM, Assistant Professor principal investigator
Adiyaman University
BARIŞ AKIN, Specialist nurse principal investigator
Mardin Training and Research Hospital
1 site 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 Harran 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 4 inclusion and 4 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 30 Dec 2025. 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?
Outcome Measures (time frame: 1 year). 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 30 Dec 2025.