Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD). Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Callmax cream application over affected skin Callmax cream or topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity.
Topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. The data on efficacy, duration of effect and frequency of application will be collected.during the study.
Shaare Zedek Medical Center
Jerusalem, Israel
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
Time frame: 1 year
quality of life assessed by questionnaire
Time frame: 1 year
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