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Completed

NCT Number: NCT01445431

A 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?

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

virgin coconut oil

Other

Virgin coconut oil applied to the test site twice daily for four weeks

Mineral Oil

Other

Mineral oil applied to the test site twice daily for four weeks

Primary outcomes

  1. Change in baseline overall dry skin score

    Time frame: 4 weeks

  2. Change in baseline corneometer readings

    Time frame: 4 weeks

    Measurement of skin hydration

  3. Change in baseline sebumeter readings

    Time frame: 4 weeks

    Measurement of skin lipids

Secondary outcomes

  1. Change in Quality of life scores

    Time frame: 4 weeks

  2. Patient-assessed efficacy

    Time frame: 4 weeks

  3. Adverse events

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 3, 2011
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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