A Phase 1/2 interventional study of application of ointment (olive-omega 3 ointment) in Uremic Pruritus, sponsored by Assaf-Harofeh Medical Center. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-10-06.
Sponsored by Assaf-Harofeh Medical Center · Phase 1/2, Interventional, and Treatment
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:
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 .
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
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Assaf-Harofeh Medical Center