Skin CareNCT06286813
The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates
A study testing Plant (natural) oils in people with Skin Care, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit. Interventional research with two parallel groups and no control group Read more about this study
- Who is it for?
- Ages 1 hour to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Plant (natural) oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2024to 30 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 hour to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.
Who cannot join
- ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34854
AYŞE KARAKOÇ, +905335695138, akarakoc@marmara.edu.tr
Irem Zulal Topçuoglu Arslan
About this study
Official title: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit
This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.
Interventional research with two parallel groups and no control group
Read the detailed description
The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.
Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.
Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study
- Conditions
- Skin Care
- Being tested
- Plant (natural) oils
- Keywords
- Newborn, skin care, extra virgin olive oil, almond oil.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant (natural) oilsOther
Using 10 ml of plant(natural) oil once a day for daily skin care of newborns
| Study group | Role | What they receive |
|---|---|---|
| Almond oil group | Experimental | On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., almond oil (10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days. Receives: Other: Plant (natural) oils |
| Extra Virgin Olive Oil Group | Experimental | On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., extra virgin olive oil(10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days. Receives: Other: Plant (natural) oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal skin condition score
This is a three-point Likert-type scale to evaluate dryness, redness, peeling / deterioration in newborn baby skin. For each criterion in the evaluation of the scale score; 1 refers to the best and 3 to the worst skin condition. The highest and lowest scores on the scale are 9 and 3, respectively. A higher scale score indicates poorer skin condition
Measured: 5 days
Skin moisture meter(DMM):
The product shows the moisture level (0%-99.9%) in contact with the skin and does not harm the skin. It provides measurement results with high precision
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start2 Mar 2024 (estimated)
- Primary completion3 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AYŞE KARAKOÇ, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286813
- Sponsor's protocol ID
- Akarakoc
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Title of study and method
Publications
Topcuoglu Arslan IZ, Karakoc A. Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit. Adv Skin Wound Care. 2025 Aug 1;38(7):381-386. doi: 10.1097/ASW.0000000000000306. Epub 2025 Apr 4.
PubMed 40184517
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06286813
- Acronym / sponsor ID
- Akarakoc
- Conditions
- Skin Care
- Keywords
- Newborn, skin care, extra virgin olive oil, almond oil.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Mar 2024 (estimated)
- Primary completion
- 3 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 29 Feb 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.
This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.
Interventional research with two parallel groups and no control group
Detailed description
The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.
Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.
Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group.
| Arm | Type | Receives |
|---|---|---|
| Almond oil group | Experimental | Other: Plant (natural) oilsOn the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., almond oil (10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days. |
| Extra Virgin Olive Oil Group | Experimental | Other: Plant (natural) oilsOn the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., extra virgin olive oil(10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.
Key exclusion criteria (1 listed)
- ; Neonates who were discharged before 5 days and required phototherapy were excluded from 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 |
|---|---|---|
| Plant (natural) oilsUsing 10 ml of plant(natural) oil once a day for daily skin care of newborns | Other | Almond oil group, Extra Virgin Olive Oil Group |
Primary outcome
Neonatal skin condition score
Time frame: 5 days
This is a three-point Likert-type scale to evaluate dryness, redness, peeling / deterioration in newborn baby skin. For each criterion in the evaluation of the scale score; 1 refers to the best and 3 to the worst skin condition. The highest and lowest scores on the scale are 9 and 3, respectively. A higher scale score indicates poorer skin condition
Skin moisture meter(DMM):
Time frame: 5 days
The product shows the moisture level (0%-99.9%) in contact with the skin and does not harm the skin. It provides measurement results with high precision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 40184517Topcuoglu Arslan IZ, Karakoc A. Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit. Adv Skin Wound Care. 2025 Aug 1;38(7):381-386. doi: 10.1097/ASW.0000000000000306. Epub 2025 Apr 4.
- Individual participant dataSharing planned: Yes. Title of study and method
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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.
AYŞE KARAKOÇ study director
Marmara 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 Plant (natural) oils in people with Skin Care, run by Marmara 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYŞE KARAKOÇ (+905335695138, akarakoc@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal skin condition score (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286813, which also lists 1 linked publication.
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 29 Feb 2024.