Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||May 2016|
|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||
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.
- Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score [ Time Frame: 1 year ]
- quality of life assessed by questionnaire [ Time Frame: 1 year ]
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
|Contact: Linda Shavit, Drfirstname.lastname@example.org|
|Shaare Zedek Medical Center||Not yet recruiting|
|Jerusalem, Israel, 91031|
|Contact: Itzchak Slotki, Dr 97226555111 email@example.com|
|Principal Investigator: Linda Shavit, Dr|
|Principal Investigator:||Itzchak Slotki, MD||Shaare Zedek Medical Center|