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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 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Tripelennamine

Tripelennamine 1% topical cream applied to the skin of one arm of an individual 15 minutes before the application of iontophoretically administered histamine 2% gel.

DRUG

Diphenhydramine

Diphenhydramine 1% topical cream applied to the skin of one arm of an individual 15 minutes before the application of iontophoretically administered histamine 2% gel.

DRUG

Vehicle Control Cream Base

Approximately 0.2 g of vehicle cream base without antihistamine was applied topically to designated forearm test areas. The cream remained on the skin for 15 minutes before histamine iontophoresis was performed.

Sponsors & Collaborators

  • Palm Beach Atlantic University

    lead OTHER

Principal Investigators

  • David M Compton, PhD · Palm Beach Atlantic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2025-09-18
Completion
2025-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07778472 on ClinicalTrials.gov