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

Pruritus Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03997851
Study type Interventional
Source University of Miami
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 22, 2019
Completion date March 18, 2020
View Details
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