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Topical Tripelennamine 1% Cream Versus Diphenhydramine 1% Cream for the Relief of Histamine-Induced Itching: A Proof Concept Study in Healthy Adults.

NCT07778472

CompletedEARLY_Phase 1

Sponsor: Palm Beach Atlantic University

Conditions: Healthy

Interventions: Tripelennamine, Diphenhydramine, Vehicle Control Cream Base

Countries: United States

The goal of this clinical trial is to determine whether topical tripelennamine 1% cream can relieve histamine-induced itching and whether it is more effective than diphenhydramine 1% cream in healthy adults aged 18 to 50 years. The main questions it aims to answer are: * Does tripelennamine 1% cream reduce the intensity, duration, and peak severity of histamine-induced itch as measured by a visual analog scale (VAS)? * Does tripelennamine 1% cream reduce the histamine-induced wheal and flare skin responses compared with diphenhydramine 1% cream and vehicle control? Researchers will compare tripelennamine 1% cream, diphenhydramine 1% cream, and a vehicle control cream base to see if tripelennamine provides greater relief of histamine-induced itching and skin reactions. Participants will: * Have four test areas marked on their forearms. * Receive topical application of tripelennamine 1% cream, diphenhydramine 1% cream, and vehicle control cream to randomized test sites. * Undergo a histamine challenge administered through iontophoresis after treatment application. * Rate their itch intensity every minute using a 0 to 10 visual analog scale until the itch subsides. * Have wheal and flare skin reactions assessed every 5 minutes for up to 20 minutes, including photographs and videos of the reactions. * Report any adverse events for up to one week after study completion.

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
* No history of chronic itch or pain.
* Must abstain from the use of any systemic or topical antihistamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
* Must abstain from the use of moisturizers on the arms 24 hours before study visit.

Exclusion Criteria:

* Inability to complete the required measures.
* The presence of an itchy skin disease.
* Diagnosis of disease that would affect itch or pain perception (e.g. neuropathies).
* Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
* Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
* Use of emollients on the arms a week prior to the study and throughout the study.
* Known allergies to tripelennamine and/or diphenhydramine.
* Pregnant women. (Women of childbearing potential will undergo an hCG pregnancy test).

Locations (1)

West Palm Beach, Florida, United States