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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

U

University of the Philippines

Status and phase

Completed
Phase 3

Conditions

Uremic Xerosis

Treatments

Other: Mineral Oil
Other: Virgin Coconut Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01445431
MED 2011-01-03-005

Details and patient eligibility

About

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?

Full 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

Enrollment

45 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

45 participants in 2 patient groups

Virgin Coconut Oil
Experimental group
Treatment:
Other: Virgin Coconut Oil
Mineral Oil
Active Comparator group
Treatment:
Other: Mineral Oil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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