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NCT Number: NCT06159686

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

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.

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Key information

Conditions

Uremic Pruritus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Thammasat

Pathum Thani, 12120, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemp

Drug

The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

Placebo

Drug

The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

Primary outcomes

  1. WI-NRS (Worst Itching Numerical Rating scale) score at week 4

    Time frame: 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.

Secondary outcomes

  1. WI-NRS at week 2

    Time frame: 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.

  2. Skindex-10 score at weeks 2 and 4

    Time frame: week 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.

  3. the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score

    Time frame: week 4

    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.

Sponsors and collaborators

Lead sponsor

Thammasat University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2023
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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