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

NCT06159686 | Completed Phase 1

• 1 other identifier: 074/2566
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremic Pruritus

Keywords

Hemp; Uremic pruritus; hemodialysis; cannabinoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• WI-NRS at week 2

  week 2

• Skindex-10 score at weeks 2 and 4

  week 2 and 4

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

  week 4

Study Arms (2)

hemp group

EXPERIMENTAL

They was assigned to apply the hemp-containing cream.

Drug: Hemp

Control group

PLACEBO COMPARATOR

They was assigned to apply the placebo cream.

Drug: Placebo

Interventions

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.

hemp group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ahistory of hemp allergy
• Pregnancy or breastfeeding
• Dermatologic diseases
• Adjustments to medications for controlling itch within the 14 days preceding the study.

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat

Pathum Thani, 12120, Thailand

Location

Related Publications (1)

• Anumas S, Kuropakornpong P, Chakkavittumrong P, Tasanarong A, Pattharanitima P. Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial. Kidney Med. 2024 Aug 21;6(10):100894. doi: 10.1016/j.xkme.2024.100894. eCollection 2024 Oct.

  PMID: 39328960 DERIVED

Study Officials

• Suthiya Anumas

  Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: September 15, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)