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

• Status: Completed
• Trial end date: 2023-12-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thammasat University Hospital

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.