Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03997851
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2019-06-24
Brief Title:
Topical Acetaminophen for Itch Relief a Proof of Concept Study in Healthy Subjects
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Topical Acetaminophen for Itch Relief a Proof of Concept Study in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 and an error probability of 005 with a power of 095 the number of participants needed is 36 10 within post hoc pairwise comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None