NCT03997851

Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.

Detailed description

This will be a single-blinded, vehicle-controlled randomized study in healthy controls to test the efficacy of the topical gel formulation with three differing concentrations of acetaminophen (APAP) for itch relief. To detect medium effects of the treatments with a given α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants needed is 36 (10 within post hoc pairwise comparisons).

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	Acetaminophen	Topical acetaminophen gel
DRUG	Carbomer 980	Topical vehicle gel

Timeline

• Start date: 2019-07-22
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2019-06-25
• Last updated: 2025-12-08
• Results posted: 2021-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study