Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

Shaare Zedek Medical Center

Status: Unknown

Conditions: Calmmax Cream on UP in CKD Patients.

Treatments: Drug: Placebo; Drug: Callmax cream application over affected skin

Study type: Interventional

Funder types: Other

Identifiers

NCT02032537

Shavit.ctil

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Callmax cream

Active Comparator group

Treatment:

Drug: Callmax cream application over affected skin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo