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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jacqueline Michelle G. de las Alas, M.D., University of the Philippines
ClinicalTrials.gov Identifier:
NCT01445431
First received: September 26, 2011
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

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?


Condition Intervention Phase
Uremic Xerosis
 Other: Virgin Coconut Oil
Other: Mineral Oil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis

Resource links provided by NLM:

MedlinePlus related topics: Minerals
U.S. FDA Resources

Further study details as provided by University of the Philippines:

Primary Outcome Measures:
  • Change in baseline overall dry skin score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in baseline corneometer readings [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measurement of skin hydration

  • Change in baseline sebumeter readings [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measurement of skin lipids


Secondary Outcome Measures:
  • Change in Quality of life scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient-assessed efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445431

Sponsors and Collaborators
University of the Philippines
Investigators
Principal Investigator: Jacqueline Michelle G de las Alas, MD University of the Philippines
  More Information

No publications provided

Responsible Party: Jacqueline Michelle G. de las Alas, M.D., Medical Officer III, University of the Philippines
ClinicalTrials.gov Identifier: NCT01445431     History of Changes
Other Study ID Numbers: MED 2011-01-03-005
Study First Received: September 26, 2011
Last Updated: September 29, 2011
Health Authority: Philippines: Philippine General Hospital Expanded Hospital Research Office

Additional relevant MeSH terms:
Mineral Oil
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013