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Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

S

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

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

Trial contacts and locations

1

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Central trial contact

Linda Shavit, Dr

Data sourced from clinicaltrials.gov

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