Clinical trial NCT06159686: The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Uremic Pruritus
Keywords: Hemp
Uremic pruritus
hemodialysis
cannabinoid
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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 is validated with second assistant.

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. The adjusted mean difference is used Analysis of Covariance (ANCOVA) , adjusted by score at baseline.

All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).

Eligibility criteria: 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.

Primary outcomes:
measure: WI-NRS (Worst Itching Numerical Rating scale) score at week 4
timeFrame: week 4
Secondary outcomes:
measure: WI-NRS at week 2
timeFrame: week 2
measure: Skindex-10 score at weeks 2 and 4
timeFrame: week 2 and 4
measure: the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score
timeFrame: week 4
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Thammasat
Study officials:
affiliation: Thammasat University
name: Suthiya Anumas
role: PRINCIPAL_INVESTIGATOR
References: