Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000122651
Ethics application status
Approved
Date submitted
12/01/2023
Date registered
6/02/2023
Date last updated
6/02/2023
Date data sharing statement initially provided
6/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Coconut oil for eczema in young children
Scientific title
Feasibility, Acceptability and Clinical Efficacy of Coconut Oil in Childhood Eczema, a pilot randomised controlled trial
Secondary ID [1] 308743 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eczema 328684 0
Condition category
Condition code
Skin 325694 325694 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is daily topical coconut oil applied to all areas of the body where moisturiser is usually applied (areas of with eczema and non-eczema). The coconut oil will be applied once per day for 12 weeks, in addition to any current eczema management regimen.

The investigational product (IP) is 100% certified organic, virgin coconut oil manufactured and supplied by Nature Pacific Pty Ltd, Varsity Lakes, Qld. This coconut oil is readily available for purchase in Australia under the trade name Tutu Virgin Coconut Oil.

At baseline clinical outpatient appointment, parents will be recruited into the study. There is a then four-week run in period to ascertain baseline eczema severity.
At the next clinical outpatient appointment, randomisation will be performed. Parents in the intervention group will receive the coconut oil and be shown how to apply the oil to their child’s skin (by treating doctor or nurse). This is a very simple procedure and will take about 10 minutes.
The coconut oil will be provided to parents in single use sachets (5ml), for daily topical application in the evening. Parents will receive an individualised treatment plan at the baseline appointment. The treatment plan is prepared by a trained clinician (nurse or doctor) in conjunction with the parent.

All children in the study have doctor diagnosed eczema. Depending on the severity, location of areas of eczema and age of the child, each child has their own individualised eczema treatment plan which is reviewed and updated at each clinic appointment. Treatment plans may include regular application of emollients, bandaging, topical corticosteroids, antimicrobial treatment, phototherapy.

The coconut oil will be used in conjunction with the patients usual prescribed eczema treatment plan; and will be applied daily regardless of eczema activity, i.e. both when there is active eczema and when the skin is clear.
Parents of children in the intervention group will be provided with an eczema management plan detailing:
1. Everyday skin care (even when there is no active eczema)
2. Application of coconut oil (once per day, to all areas of body, after bath/shower in the evening)
3. Application of coconut oil when there is an eczema flare-up
4. Specific recommendations per individual patient made by the treating clinician. This plan is reviewed at each clinic follow up appointment.
Adherence to the use of coconut oil will be monitored by:
1. Parents are asked to retain the empty coconut oil sachets and bring them to the next outpatient clinic appointment
2. Parents are asked to complete a daily e-diary, recording if daily coconut oil was applied, the time of application, the reason if coconut oil was not applied, if the child had active eczema, and other eczema treatment that day. The diary also details any reactions to the application of coconut oil.

Patients in the control group will continue with their individualised eczema care plan, ensuring that they do not use coconut oil in any form, and apply sorbelene cream at least once daily.
Intervention code [1] 325204 0
Treatment: Other
Comparator / control treatment
Children attending the Perth Children's Hospital outpatient clinic for treatment of eczema will have a doctors diagnosis of eczema and an eczema management plan which may include regular application of creams or emollients in combination with prescribed medications (oral steroids, corticosteroid creams). The control group will continue their current eczema management plan with strict avoidance of topical coconut oil or other topical products containing coconut oil.
Control group
Active

Outcomes
Primary outcome [1] 333546 0
Patient Oriented Eczema Measure (POEM) will be used to record serial change in parental perceived severity of eczema during the study. The parents will complete the POEM online
Timepoint [1] 333546 0
This study will run over a 20 week period consisting of Baseline and screening (W0), run-in period 0 to 4 weeks (W4), treatment period, 4 to 16 weeks (W8, W12, W16), end of treatment W16, and end of study W20. Children and parents will be asked attend 6 outpatient clinics.

The POEM will be completed weekly online by parents from baseline - W0 to W20.
Primary outcome [2] 333547 0
Eczema Area and Severity Index (EASI) will be completed at each clinic appointment by the treating clinician, to assess clinical (objective) severity of eczema
Timepoint [2] 333547 0
Baseline W0, W4, W8, W12, W16, and W20 (end of study)
Primary outcome [3] 333548 0
Assessment of adherence to treatment
The participant e-diary is sent daily to parents. Adherence to treatment will be assessed by recording the daily application of coconut oil during the treatment period.
Full adherence to treatment will be defined as application of the IP on an average of 5 or more days per week during the intervention period
Partial adherence to treatment will be defined as application of the IP on an average of 3-5 days per week during the intervention period
Non-adherence to treatment will be defined as application of the IP on an average of fewer than 3 days per week during the intervention period
Timepoint [3] 333548 0
Daily parental response via e-diary during the treatment period - W4 to W16 (from baseline W0)
Secondary outcome [1] 417487 0
To describe microbiological changes associated with topical coconut oil use.
Pre-wetted (saline) Nylon FLOQ swabs will be used to swab a 10cm2 area of skin encompassing the most severe eczema lesion along with a neighbouring skin site unaffected by eczema. The two swabs will be collected at baseline and then each time point throughout the intervention period at the follow up clinic appointment by the treating clinician. Changes in skin microbial colonisation and bacterial load (colony forming units/cm2), particularly Staphylococcus spp in response to topical coconut oil use, will be measured.
Timepoint [1] 417487 0
Swabs will be collected at baseline W0, W4, W8, W12, W16, and W20 (end of study)
Secondary outcome [2] 417488 0
Development of allergic sensitisation to coconut will be measured as a positive skin prick to coconut at end of trial. A skin prick test for coconut will be performed at the baseline and the end of the treatment
Timepoint [2] 417488 0
Skin prick test at baseline W0 and end of treatment W16.
Secondary outcome [3] 417489 0
To assess impact on health related disease specific quality of life
We will assess changes in Infants’ dermatitis quality of life index (IDQOL). THe IDQOL will be completed electronically by the parents of children below the age of four years.
Timepoint [3] 417489 0
The IDQOL will be completed online by parents at baseline W0, end of run-in period W4, end of treatment W16 and at the end of study W20.
Secondary outcome [4] 417879 0
Children’s Dermatology Life Quality Index (CDLQI) will be completed electronically by parents to assess impact on quality of life.
Timepoint [4] 417879 0
The IDQOL will be completed online by parents at baseline W0, end of run-in period W4, end of treatment W16 and at the end of study W20.
Secondary outcome [5] 417880 0
Assessment of allergy to coconut
Venous blood samples will be drawn at baseline and the end of the study to assess specific IgE to coconut. The samples will be stored to enable further analysis of other immunological and metabolic changes associated with topical coconut oil application and eczema
Timepoint [5] 417880 0
A blood sample will be requestest at baseline (W0) and end of treatment period (W16)
Secondary outcome [6] 417881 0
Adverse events
Participants’ parent/guardian will be sent a link for a daily electronic diary to complete via direct entry into REDCap. The daily diary will also capture information about any adverse events the participants experience in response to the coconut oil treatment, and other illnesses and hospital admissions.
Timepoint [6] 417881 0
Daily parental response via e-diary during the study period - from baseline W0 to end of study W20.

Eligibility
Key inclusion criteria
1. Male of female children from 0-5 years of age (ie first visit to occur prior to child’s sixth birthday).
2. Confirmed doctor diagnosis of eczema (mild, moderate or severe).
3. At least 1 episode of active eczema within the 4 week run-in period (defined as use of topical steroids for eczema on at least 1 day during the 4 week period).
4. Negative SPT to coconut at baseline (< /=3mm)
Minimum age
0 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with a diagnosed coconut allergy or known hypersensitivity to topical coconut oil.
2. Participants who have received oral immunosuppression or other systemic therapy for eczema in the last 3 months
3. Participants who have been hospitalised for treatment of eczema in the last 6 months
4. Participants who have used bleach baths in the last 3 months
5. Participants who have used other antimicrobial treatments for eczema in the last 3 months
6. Participants with other chronic skin conditions that may interfere with assessment of eczema severity and/or response to treatment (e.g. ichthyosis vulgaris, psoriasis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer softward
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We will enrol 60 participants in this pilot study. Robust sample size calculations are not possible for this small pilot study. This sample size is feasible to recruit in the timeframe proposed and we anticipate it will provide sufficient preliminary data to inform the design, including required sample size, for future studies to demonstrate the efficacy of the intervention.

This is a pilot study, with estimates of clinical effects of the intervention compared to standard care being used to inform the design future trials to confirm the efficacy of the intervention. We will perform between group comparisons for each primary and secondary outcome at the end of the study.
Participant characteristics will be compared using Chi-Square test or a Fishers Exact test. To examine the clinical effects of the study intervention, analysis of covariance will be used to compare the mean post-intervention POEM and EASI scores between the intervention and standard care groups, conditioning on baseline scores for each instrument.
Total amount of topical steroid used during the intervention period will be calculated for each participant, and the intervention and control groups compared using the Mann-Whitney U test.
Adverse events, including SAEs and TEAESIs, will be reported in frequency tables. The proportion of participants experiencing AEs in each group will be calculated.
Overall treatment adherence (total number of days on which the IP was applied divided by total number of days in the intervention period for all participants) will be calculated. The proportion of participants with full, partial and non-adherence to treatment will be calculated.
A difference in proportions along with the corresponding 95% confidence interval will also be produced. Odds ratios and their 95% confidence intervals will be produced via logistic regression. Adjusting for potential confounders such as family history, gender, ethnicity and food allergy will be considered when performing logistic regression. Secondary outcomes with continuous data (coconut SPT wheal size and sIgE) will be analysed using Student t-tests or the Mann-Whitney U test if the data do not meet the assumptions for parametric tests and cannot be normalized by using logarithmic transformation. Analysis will primarily be on all consented participants in an intention-to-treat analysis. Subgroup analyses will be performed for participants based on adherence (full, partial or non-adherence). Any eventual deviation from the original statistical plan will be described and justified in the final report, as appropriate. Where individuals do not have a full data set, each variable will be assessed on a case-by-case basis (rather than excluding all data). Any data suspected as false will be treated as missing data. Stata will be used to analyse data and create graphs and/or figures. Alpha will be set at 0.05.
No interim analysis is planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23821 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 39274 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312965 0
Government body
Name [1] 312965 0
Western Australian Department of Health
Country [1] 312965 0
Australia
Funding source category [2] 313124 0
Commercial sector/Industry
Name [2] 313124 0
Northern Star Resources Limited
Country [2] 313124 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital (Child and Adolescent Health Service)
Address
Perth Children's Hospital
15 Hospital Ave,
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 314655 0
None
Name [1] 314655 0
Address [1] 314655 0
Country [1] 314655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312236 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312236 0
Ethics committee country [1] 312236 0
Australia
Date submitted for ethics approval [1] 312236 0
04/04/2022
Approval date [1] 312236 0
14/06/2022
Ethics approval number [1] 312236 0
RGS0000005399

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123942 0
Dr Michael O'Sullivan
Address 123942 0
Department of Immunology
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 123942 0
Australia
Phone 123942 0
+61 8 6152 8006
Fax 123942 0
Email 123942 0
michael.o'[email protected]
Contact person for public queries
Name 123943 0
Michael O'Sullivan
Address 123943 0
Department of Immunology
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 123943 0
Australia
Phone 123943 0
+61 8 6152 8006
Fax 123943 0
Email 123943 0
michael.o'[email protected]
Contact person for scientific queries
Name 123944 0
Michael O'Sullivan
Address 123944 0
Department of Immunology
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 123944 0
Australia
Phone 123944 0
+61 8 6152 8006
Fax 123944 0
Email 123944 0
michael.o'[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.