NCT01447693

Brief Summary

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. 1.\- patches of fine , powdery scales
  2. 2.\- moderate scaling with beginning cracks
  3. 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.
  4. 4.very good
  5. 5.good
  6. 6.poor
  7. 7.\- very satisfactory
  8. 8.\- satisfactory 3- poorly satisfactory.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2007

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

First QC Date

December 31, 2007

Last Update Submit

October 5, 2011

Conditions

Keywords

uremiapruritusoliva-omega 3

Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis patients which have treated at least 3 months

You may not qualify if:

  • Dermatologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

UremiaPruritus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 31, 2007

First Posted

October 6, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10