Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

Study Overview
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Brief Summary
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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.

Conditions
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Calmmax Cream on UP in CKD Patients.

Intervention / Treatment
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* Drug: Callmax cream application over affected skin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of pruritus of >8 weeks duration. Severity score of pruritus ≥5 as defined by VAS Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream) Negative pregnancy test result for all participating women of childbearing age; Exclusion Criteria: Known allergy to Calmmax cream Any acute illness Liver cirrhosis Active dermatological disorder other than UP Decompensated heart failure Inability to give informed consent Known poor adherence to medical recommendations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Callmax cream<br> | Drug: Callmax cream application over affected skin<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life assessed by questionnaire |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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callmax cream, uremic pruritus