Treatment of Uremic Pruritus by Olive-omega 3 Ointment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01447693
First received: December 31, 2007
Last updated: October 5, 2011
Last verified: October 2011

December 31, 2007
October 5, 2011
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Complete list of historical versions of study NCT01447693 on ClinicalTrials.gov Archive Site
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Treatment of Uremic Pruritus by Olive-omega 3 Ointment
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Background.

Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis.

The pathogenesis of uremic itch remains unclear. Several theories have been proposed like dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.

Many treatment modalities have been tried to reduce uremic pruritus, however , the majority of them produced only temporary improvement. Therefore , every new therapeutic option for uremic pruritus is desirable.

This study will undertaken to evaluate the efficacy of a cream which included olive oil and omega-3 fatty acids.

Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.

The product is unique and based on patented technology developed by the Technion Research and Development Foundation in Haifa.

Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty acids that are vital for its proper functioning and help in the skin recovery. Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing water retention in the upper layer of the skin.

When applied on clean skin , the product is quickly absorbed , producing a sensation of relief within a short time period. Treatment can be repeated as often as required with no limitations and its use is not contraindicative of any other medical treatment.

Patients and Methods.

About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in the study.

All patients will undergo dermatologic examination. All patients will be score by intensity of itching according to 3-point scale , as follows:

  1. - patches of fine , powdery scales
  2. - moderate scaling with beginning cracks
  3. - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for 50% of body and Vaseline ointment for the second one. The treatment will repeated twice daily for two weeks.

At the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:

  1. very good
  2. good
  3. poor

At the same time global agreement of the patients will evaluate according to the following scale :

  1. - very satisfactory
  2. - satisfactory 3- poorly satisfactory.

Statistical analysis will be performed by use of Wilcoxon test .

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uremic Pruritus
Procedure: application of ointment (olive-omega 3 ointment)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
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Inclusion Criteria:

  • Hemodialysis patients which have treated at least 3 months

Exclusion Criteria:

  • Dermatologic diseases
Both
18 Years to 90 Years
No
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NCT01447693
130/06
No
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Assaf-Harofeh Medical Center
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Assaf-Harofeh Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP