Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

Not Applicable

• Conditions: Calmmax Cream on UP in CKD Patients.
• Interventions: Drug: Callmax cream application over affected skin; Drug: Placebo

• Registration Number: NCT02032537
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10
• Study Start: 2014-11
• Primary Completion: 2015-11
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Callmax cream	Callmax cream application over affected skin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score	1 year

Secondary Outcome Measures

Name	Time	Method
quality of life assessed by questionnaire	1 year

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel