Clinical Trial
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Efficacy and tolerance of the cream containing structured physiological lipids with endocannabinoids in the treatment of uremic pruritus: a preliminary study.

Uremic pruritus is still a common phenomenon in patients with end-stage renal failure, however, there is no effective treatment of choice for this condition. This study was undertaken to evaluate the efficacy and tolerance of the cream with structured physiological lipids (DMS, Derma Membrane Structure) and endogenous cannabinoids in controlling pruritus in patients on maintenance hemodialysis. Twenty-one subjects with uremic pruritus completed the trial. All patients applied the tested cream twice daily for a period of three weeks. Pruritus was evaluated using two pruritus scoring methods: standard visual analog scale (VAS) and a questionnaire method. Moreover, all patients had dry skin scored according to the 5-point scale. Global pruritus and xerosis were examined before the trial, on study visits at weekly intervals, and on follow-up visit performed two weeks of study discontinuation. After 3-week therapy pruritus was completely eliminated in 8 (38.1%) patients. Pruritus evaluation by both scales revealed significant reduction of pruritus scores (p<0.0001) during the tested product application. At the beginning of the trial there was no significant correlation between the intensity of dry skin and severity of pruritus. The 3-week treatment period resulted in complete reduction of xerosis in 17 (81%) patients, while xerosis scores were significantly reduced (p=0.0001) throughout the study period. The test product was very well tolerated by all patients. The test product appeared to be effective in reducing both pruritus and xerosis in hemodialysis patients. It is very probable that the observed decrease of pruritus with the test product therapy was not only the result of dry skin improvement but that the addition of endocannabinoids may have also played a role. These preliminary results are encouraging, however, additional controlled studies are needed to clarify the exact usefulness of this product in therapy of uremic pruritus.

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