Treatment of Uremic Pruritus by Olive-omega 3 Ointment
|ClinicalTrials.gov Identifier: NCT01447693|
Recruitment Status : Unknown
Verified October 2011 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 6, 2011
Last Update Posted : October 6, 2011
|First Submitted Date ICMJE||December 31, 2007|
|First Posted Date ICMJE||October 6, 2011|
|Last Update Posted Date||October 6, 2011|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Treatment of Uremic Pruritus by Olive-omega 3 Ointment|
|Official Title ICMJE||Not Provided|
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:
At the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:
At the same time global agreement of the patients will evaluate according to the following scale :
Statistical analysis will be performed by use of Wilcoxon test .
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Uremic Pruritus|
|Intervention ICMJE||Procedure: application of ointment (olive-omega 3 ointment)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||20|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 90 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT01447693|
|Other Study ID Numbers ICMJE||130/06|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Assaf-Harofeh Medical Center|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Assaf-Harofeh Medical Center|
|Verification Date||October 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP