Clinical Research Directory

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

Sponsor: Palm Beach Atlantic University

Summary

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.

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