Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

Calmmax Cream on UP in CKD Patients. Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02032537
• Other study ID #: Shavit.ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: January 8, 2014
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2014
• Source: Shaare Zedek Medical Center
• Contact: Linda Shavit, Dr
• Phone: 97226555111
• Email: lshavit[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calmmax Cream on UP in CKD Patients.

Intervention

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
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.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score		1 year	No
Secondary	quality of life assessed by questionnaire		1 year	Yes