Back to resultsEfficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
Primary Purpose
Calmmax Cream on UP in CKD Patients.
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Callmax cream application over affected skin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Calmmax Cream on UP in CKD Patients. focused on measuring callmax cream, uremic pruritus
Eligibility Criteria
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
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Callmax cream
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
Secondary Outcome Measures
quality of life assessed by questionnaire
Full Information
NCT ID
NCT02032537
First Posted
January 6, 2014
Last Updated
January 8, 2014
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02032537
Brief Title
Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calmmax Cream on UP in CKD Patients.
Keywords
callmax cream, uremic pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Callmax cream
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Callmax cream application over affected skin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
quality of life assessed by questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Shavit, Dr
Phone
97226555111
Email
lshavit@szmc.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itzchak Slotki, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itzchak Slotki, Dr
Phone
97226555111
Email
islotki@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Linda Shavit, Dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived
Learn more about this trial
Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
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