Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

January 8, 2014 updated by: Linda Shavit, Shaare Zedek Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. History of pruritus of >8 weeks duration.
  2. Severity score of pruritus ≥5 as defined by VAS
  3. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
  4. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

  1. Known allergy to Calmmax cream
  2. Any acute illness
  3. Liver cirrhosis
  4. Active dermatological disorder other than UP
  5. Decompensated heart failure
  6. Inability to give informed consent
  7. Known poor adherence to medical recommendations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
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.
Active Comparator: Callmax cream
Drug: Callmax cream application over affected skin
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life assessed by questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Itzchak Slotki, MD, Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shavit.ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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