None listed
Conditions
Brief summary
The aim of this study is to investigate whether topical coconut oil is effective and safe as a maintenance treatment of eczema in young children. We hypothesize that topical coconut oil in children with eczema will be beneficial in reducing disease severity and frequency of eczema flares through its combined effect of anti-microbial and anti-inflammatory properties Eczema is a common chronic inflammatory skin disorder characterised by dry itchy skin, and is one of the most common skin conditions affecting young children. Cracked and dry skin caused by eczema leads to loss of moisture, a dysregulated immune system causing inflammation and changes the composition of bacterial that naturally occur on children’s skin which that may cause infection and disease flares. In addition, eczema often is the start of the allergic reactions with a significant proportion of these children going on to develop other allergies, including food allergies, hayfever and allergic asthma. Regular liberal application of creams or emollients is an integral part of eczema management which improves and maintains the skin barrier, in combination with prescribed medications (i.e. corticosteroid creams) when there is active eczema flares. Trying to avoid eczema recurring with emollient use alone does not appear to prevent reoccurring eczema flares, leading to ongoing cycles requiring the use of medications, patient suffering and frustrated caregivers. Coconut oil is rich in fatty acids, which have natural activity against microbes and inflammation. Coconut oil for skin care has been shown to improve skin condition. Our laboratory studies have shown that Monolaurin (the primary fatty acid in coconut oil), at the concentrations present in the coconut oil used for skin care, has substantial antimicrobial activity, particularly against bacteria that commonly cause eczema flares. We propose to conduct a practical, pilot, randomised controlled trial (RCT), to investigate the effects of daily topical coconut oil in 60 children under 6 years of age with doctor diagnosed eczema. Participants will be randomised to either apply daily topical 100% certified organic, virgin coconut oil, or to standard care (topical coconut oil avoidance) for a period of 12 weeks. This study will provide valuable pilot data for the potential role of coconut oil in children with eczema, which will be used to design future large multi-centre studies.
Interventions
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
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.
Sponsors
Perth Children's Hospital (Child and Adolescent Health Service)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 5 Years
Healthy volunteers
No
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)
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)
Outcome results
None listed