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Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

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ClinicalTrials.gov Identifier: NCT02032537
Recruitment Status : Unknown
Verified January 2014 by Linda Shavit, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Linda Shavit, Shaare Zedek Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Calmmax Cream on UP in CKD Patients. Drug: Callmax cream application over affected skin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. quality of life assessed by questionnaire [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032537


Contacts
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Contact: Linda Shavit, Dr 97226555111 lshavit@szmc.org.il

Locations
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Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Itzchak Slotki, Dr    97226555111    islotki@szmc.org.il   
Principal Investigator: Linda Shavit, Dr         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Itzchak Slotki, MD Shaare Zedek Medical Center

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Responsible Party: Linda Shavit, Dr, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02032537     History of Changes
Other Study ID Numbers: Shavit.ctil
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Linda Shavit, Shaare Zedek Medical Center:
callmax cream
uremic pruritus