A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 45
- Primary Endpoint
- Change in baseline overall dry skin score
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mineral Oil
Intervention: Mineral Oil (Other)
Virgin Coconut Oil
Intervention: Virgin Coconut Oil (Other)
Outcomes
Primary Outcomes
Change in baseline overall dry skin score
Time Frame: 4 weeks
Change in baseline corneometer readings
Time Frame: 4 weeks
Measurement of skin hydration
Change in baseline sebumeter readings
Time Frame: 4 weeks
Measurement of skin lipids
Secondary Outcomes
- Change in Quality of life scores(4 weeks)
- Patient-assessed efficacy(4 weeks)
- Adverse events(4 weeks)
Investigators
Jacqueline Michelle G. de las Alas, M.D.
Medical Officer III
University of the Philippines