- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032537
Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda Shavit, Dr
- Phone Number: 97226555111
- Email: lshavit@szmc.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
-
Contact:
- Itzchak Slotki, Dr
- Phone Number: 97226555111
- Email: islotki@szmc.org.il
-
Principal Investigator:
- Linda Shavit, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
|
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
|
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
Sponsor
Investigators
- Principal Investigator: Itzchak Slotki, MD, Shaare Zedek Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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