A Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis

Study Overview
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Brief Summary
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Among adult patients with chronic kidney disease undergoing hemodialysis, what is the efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic moisturizer for uremic xerosis?

Detailed Description
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Objectives of the Study: The general objective of this study is to assess the efficacy and safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post and 4-weeks post application; 2) to quantitatively measure the following skin parameters at baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin lipids using a sebumeter); 3) to determine and compare changes in quality of life scores within and between treatment groups at baseline, and 4-weeks post application; and 4) to identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer for uremic xerosis

Official Title
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A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis

Conditions
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Uremic Xerosis

Intervention / Treatment
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* Other: Virgin Coconut Oil
* Other: Mineral Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis Exclusion Criteria: Patients with known hypersensitivity to the tests oils were excluded from the study as well as patients with open wounds, erosions, and ulcers on the test site and paraplegics and patients with altered sensation on the test sites. Patients with xerosis associated with other dermatologic conditions antedating renal failure were excluded from the study.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virgin Coconut Oil<br> | Other: Virgin Coconut Oil<br>* Virgin coconut oil applied to the test site twice daily for four weeks<br>|
| Active Comparator: Mineral Oil<br> | Other: Mineral Oil<br>* Mineral oil applied to the test site twice daily for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline overall dry skin score |  | 4 weeks | 
| Change in baseline corneometer readings | Measurement of skin hydration | 4 weeks | 
| Change in baseline sebumeter readings | Measurement of skin lipids | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life scores |  | 4 weeks | 
| Patient-assessed efficacy |  | 4 weeks | 
| Adverse events |  | 4 weeks |