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Diaper RashNCT05328232

The Effect Of Olive Oil on Diaper Rash

A study testing Olive oil in people with Diaper Rash and Olive Oil, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: Diaper rash is an irritating, common skin problem in newborns and young children and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and irritation. Read more about this study

Who is it for?
Ages 0 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Diaper Rash, Olive Oil
What is being tested?
Olive oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2020to 31 Dec 2020
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 0 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Having a first-degree diaper rash
  • Being 0-24 months old
  • Having the family's consent indicating that they allow their child to be included in the study

Who cannot join

  • The baby's having anorectal congenital anomaly
  • The baby's having an obstacle to the application of olive oil (allergy, etc.)
  • Having a second-degree or third-degree rash

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Karamanoglu Mehmetbey University

    Karaman, Central, 70100

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Olive Oil Use on The Healing of Diaper Rash

Objective: Diaper rash is an irritating, common skin problem in newborns and young children and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and irritation. This experimental study was planned to investigate the effect of olive oil use on the healing of diaper rash in infants with first-degree diaper rash undergoing treatment in an infant ward.

Methods: The study conducted between September 2020 and December 2020 included 37 infants aged 0-24 months who were treated for any reason in the Infant Clinic of a medical school and had first-degree rash. The infants in the experimental and control groups were "treated with olive oil and X brand cream" respectively. The X brand cream and the effects of olive oil and X brand cream use on the improvement of diaper rash were compared.

Being tested
Olive oil
Medical subject headings
Diaper Rash

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olive oilOther

    The parents of the babies included in the experimental group were asked to fill in the questionnaires. The infant's skin condition was assessed using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants. Each time the diaper was changed, the diaper area was cleaned with water and cotton wool and dried, 1-2 cc of natural extra virgin olive oil was applied, and the new diaper was fastened. At the end of each day, the diaper area was evaluated by the researcher and a nurse by using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants.

Study groups in NCT05328232
Study groupRoleWhat they receive
Olive oilExperimentalNot described
Receives: Other: Olive oil
Routine careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups.

    comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups

    Measured: October-November 2020 (two months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start1 Sep 2020
  3. Primary completion1 Nov 2020
  4. Study completion31 Dec 2020

Resources

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328232
Sponsor's protocol ID
2020/09
Status last verified
Apr 2022
First submitted
30 Mar 2022
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Adalat S, Wall D, Goodyear H. Diaper dermatitis-frequency and contributory factors in hospital attending children. Pediatr Dermatol. 2007 Sep-Oct;24(5):483-8. doi: 10.1111/j.1525-1470.2007.00499.x. PMID: 17958792. 2. Atherton DJ. The Aetiology and Management of Irritan Diaper Dermatitis. European Academy of Dermatology and Venereology, 2001;15:1-4. 3. Al-Waili N.S. Clinical and Mycological Benefits of Topical Application of Honey, Olive oil and Beeswax in Diaper Dermatitis. Clinical Microbiology and Infection, 2005;11(2): 141-163. 4. Arısoy A, Canbulat N, Ayhan A. Karaman İlindeki Annelerin Bebeklerinin Bakımında Uyguladıkları Geleneksel Yöntemler. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 2014;17(1): 23-32. 5. Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants, Development and Validation. Pediatric Dermatology, 2016,33(6):632-639. 6. Danby SG, Alenezi T, Sultan A, Lavender T, Chittock J, Brown K, Cork MJ. Effect of Olive and Sunflower Seed Oil on the Adult Skin Barrier, İmplications for Neonatal Skin Care. Pediatric Dermatology, 2013;30(1):42-50. 7. Duffy LJ, Ferguson MR, Darmstadt LG. Opportunities for Improving, Adapting and Introducing Emollient Therapy and Improved Newborn Skin Care Practices in Africa. Journal of Tropical Pediatrics. 2012;58(2): 88-95. 8. Felter SP, Carr AN, Zhu T, Kirsch T, Niu G. Safety Evaluation for İngredients Used in Baby Care Products: Consideration of Diaper Rash. Regulatory Toxicology and Pharmacology, 2017;90:214-221. 9. Fölster-Holst R. Differential Diagnoses of Diaper Dermatitis. Pediatric Dermatology, 2018;35:10-18. 10. Gözen D, Çağlar S, Bayraktar S, Atıcı F. Diaper Dermatitis Care of Newborns Human Breast Milk or Barrier Cream. Journal of Clinical Nursing, 2013;23(3-4):515-523. 11. Gupta AK, Skinner AR. Management of Diaper Dermatitis. Int J Dermatol, 2004;43: 830-834. 12. Kenner C, Lott JW, Flandermeyer A. A Comprehensive Neonatal Nursing. WB Saunders, Philadelphia, 1998;2:67-58. 13. Keskin E. Bebeklerde Komplike Olmayan Bez Dermatiti Şiddet Değerlendirme Ölçeğinin Geçerlik ve Güvenirliğinin İncelenmesi. Yüksek Lisans Tezi, Ege Üniversitesi Sağlık Bilimleri Enstitüsü, 2019, İzmir. 14. Kohlendorfer-Kiechl U, Berger C. Inzinger R. The Effect of Daily Treatment with an Olive Oil/Lanolin Emollient on Skin Integrity in Preterm Infants: A Randomized Controlled Trial. Pediatric Dermatology. 2008;25(2): 174178. 15. Kirlek F. Erken Pospartum Dönemde Meme Başı Ağrısı ve Çatlaklarının Önlenmesinde Anne Sütü ve Zeytinyağının Etkisi. Yüksek Lisans Tezi, Adnan Menderes Üniversitesi Sağlık Bilimleri Enstitüsü, 2010, Aydın. 16. Lupiáñez-Pérez I, Morilla-Herrera JC, Ginel-Mendoza L, Martín-Santos FJ, Navarro-Moya FJ, Sepúlveda-Guerra RP, Morales-Asencio JM. Effectiveness of Olive Oil for the Prevention of Pressure Ulcers Caused in İmmobilized Patients Within the Scope of Primary Health Care, Study Protocol for A Randomized Controlled Trial. Trials, 2013;14(1):1-7. 17. Mandleco BL. Theoretical Approaches to the Growth and Development of Children. In Pediatric Nursing Caring for Children and Their Families. (Eds). Micki L. Potts. United States of America. Delmar Thomsan Learning. 2002. 18. Nield LS, Kamat D. Prevention, Diagnosis and Management of Diaper Dermatitis. Clin Pediatr, 2007;46:480-486. 19. Önder M, Adışen E, Velagiç Z. Diaper Dermatit. Çocuk Sağlığı ve Hastalıkları Dergisi, 2007;50:129-135. 20. Panahi Y, Sharif MR, Sharif A, Beiraghdar F, Zahiri Z, Amirchoopani G, Sahebkar A. A Randomized Comparative Trial on the Therapeutic Efficacy of Topical Aloe Vera and Calendula Officinalis on Diaper Dermatitis in Children. The Scientific World Journal, 2012;20(12):1-5. 21. Pingvini S, Shahsavari S, Gazerani F, Abdolkavand S. Topical Use of Human Breast Milk for Diaper Rash in İnfants. Middle East Journal of Nursing, 2009;3:27-30. 22. Prasad HRY, Srivastava P, Verma KK. Diaper Dermatitis an Overview. The Indian Journal of Pediatrics, 2003;70(8):635-637. 23. Salam AR, Das KJ, Darmstadt LG, Bhutta AZ. Emollient Therapy for Preterm Newborn Infants-Evidence From the Developing World. BMC Public Health. 2013;13(3): 31-37. 24. Scheinfeld N. Diaper dermatitis. American journal of clinical dermatology, 2005;6(5): 273-281. 25. Sharifi-Heris Z, Amiri-Farahani L, Haghani H, Abdoli-Oskouee S, Hasanpoor-Azghady S. Comparison the Effects of Topical Application of Olive and Calendula Ointments on Children's Diaper Dermatitis. A Triple-blind Randomized Clinical Trial. Wiley Dermatology Therap, 2018;10(11):1-7. 26. Šikić Pogačar M, Maver U, Marčun Varda N, Mičetić-Turk D. Diagnosis and Management of Diaper Dermatitis in İnfants with Emphasis on Skin Microbiota in the Diaper Area. International Journal of Dermatology, 2018;57(3):265-275.

Questions about this trial

What is this clinical trial studying?

A study testing Olive oil in people with Diaper Rash and Olive Oil, run by Karamanoğlu Mehmetbey 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 3 inclusion and 3 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 14 Apr 2022. 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?

Comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups. (time frame: October-November 2020 (two months)). 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 NCT05328232, 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 14 Apr 2022.

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