The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus

Study Overview
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Brief Summary
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Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms. This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.

Detailed Description
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Eligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant. As this study was a pilot study, we planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant. As this study was a pilot study, we planned a sample size of 60 participants to detect differences in itching scores within each group. To prevent missing data, we planned to collect 66 participants, which is a 10% increase. For statistical analysis, continuous variables are compared using an unpaired t-test or Mann-Whitney U test, as appropriate. Categorical variables are compared using a Chi-square test or Fisher's exact test. All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas). g scores within each group. But for prevention of missing data we plan collected 66 participants. (+10%) For statistical analysis, continuous variables are compared using an unpaired t-test or Mann-Whitney U test, as appropriate. Categorical variables are compared using a Chi-square test or Fisher's exact test. All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).

Official Title
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This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients. Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2, 4.

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: Hemp
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years old, diagnosed with end-stage kidney disease Undergoing thrice-weekly chronic hemodialysis for more than 90 days Exhibit a WI-NRS score of 3 or higher Exclusion Criteria: Ahistory of hemp allergy Pregnancy or breastfeeding Dermatologic diseases Adjustments to medications for controlling itch within the 14 days preceding the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hemp group<br>They was assigned to apply the hemp-containing cream. | Drug: Hemp<br>* The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.<br>|
| Placebo Comparator: Control group<br>They was assigned to apply the placebo cream. | Drug: Placebo<br>* The application of the placebog cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WI-NRS (Worst Itching Numerical Rating scale) score at week 4 | WI-NRS score will demonstrate the severity of itch at week 4. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome. | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WI-NRS at week 2 | WI-NRS score will demonstrate the severity of itch at week 2. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome. | week 2 | 
| Skindex-10 score at weeks 2 and 4 | Skindex-10 score will demonstrate the itch-related quality of life at week 2 and 4. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome. | week 2 and 4 | 
| the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score | The change of WI-NRS score and Skindex-10 score between baseline and week 4 represents the change of severity and QOL after complete study (week4) compare to baseline. The greater different scores mean a better outcome. | week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemp, Uremic pruritus, hemodialysis, cannabinoid