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

NCT03997851 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-08

Study results available
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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.

Conditions

Interventions

DRUG

Acetaminophen

Topical acetaminophen gel

DRUG

Carbomer 980

Topical vehicle gel

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Gil Yosipovitch, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2020-03-18
Completion
2020-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997851 on ClinicalTrials.gov