- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800352
The Effect of Olive Oil and Centaury Oil on Rash
Investigation of the Effect of Olive Oil and Centaury Oil in the Management of Diaper Dermatitis
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mardin, Turkey (Türkiye)
- Mardin Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Olive Oil Application
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.
|
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.
|
|
Experimental: Centaury Oil Application
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: H YAĞMUR SEVİNÇ AKIN, Assistant Professor, Harran University
- Principal Investigator: MAKSUDE YILDIRIM, Assistant Professor, Adiyaman University
- Principal Investigator: BARIŞ AKIN, Specialist nurse, Mardin Training and Research Hospital
- Principal Investigator: NESRİN ŞEN CELASİN, Assoc. Professor, Celal Bayar University
- Principal Investigator: ZÜLEYHA GÜRDAP, RESEARCH ASSISTANT, Inonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRU-VSYO-HYSA-2024/139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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