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

Uremic Pruritus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159686
• Other study ID #: 074/2566
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 15, 2023
• Est. completion date: December 8, 2023

Study information

• Verified date: March 2024
• Source: Thammasat University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• Hemp
The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
• Placebo
The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

Locations

Country	Name	City	State
Thailand	Thammasat	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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