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

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

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?

Study Overview

• Status: Completed
• Conditions: Uremic Xerosis
• Intervention / Treatment: Other: Virgin Coconut Oil; Other: Mineral Oil

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virgin Coconut Oil	Other: Virgin Coconut Oil; Virgin coconut oil applied to the test site twice daily for four weeks
Active Comparator: Mineral Oil	Other: Mineral Oil; Mineral oil applied to the test site twice daily for four weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Philippines
• Investigators: Principal Investigator: Jacqueline Michelle G de las Alas, MD, University of the Philippines

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): October 3, 2011

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 29, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: MED 2011-01-03-005