Calmmax Cream on UP in CKD Patients.
Conditions
Keywords
callmax cream, uremic pruritus
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.
Interventions
DRUGCallmax 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.
DRUGPlacebo
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.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| quality of life assessed by questionnaire | 1 year |
Countries
Israel
Contacts
Primary ContactLinda Shavit, Dr
Outcome results
None listed