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

Phase 3

Completed

• Conditions: Uremic Xerosis
• Interventions: Other: Virgin Coconut Oil; Other: Mineral Oil

• Registration Number: NCT01445431
• Lead Sponsor: University of the Philippines

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-29
• Last Update Submitted: 2011-09-29
• Study First Posted: 2011-10-03
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virgin Coconut Oil	Virgin Coconut Oil	-
Mineral Oil	Mineral Oil	-

Primary Outcome Measures

Name	Time	Method
Change in baseline overall dry skin score	4 weeks
Change in baseline corneometer readings	4 weeks	Measurement of skin hydration
Change in baseline sebumeter readings	4 weeks	Measurement of skin lipids

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life scores	4 weeks
Patient-assessed efficacy	4 weeks
Adverse events	4 weeks