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Old antihistamine, new trick: could tripelennamine cream outperform diphenhydramine for itch?

NCT ID NCT07778472

Symptom relief Sponsor: Palm Beach Atlantic University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether a topical cream containing tripelennamine, an older antihistamine, can relieve itching caused by histamine. Healthy adults aged 18 to 50 will have the cream applied to their forearms before a histamine challenge, and their itch intensity and skin reactions will be compared against diphenhydramine cream and a placebo. The goal is to see if tripelennamine offers faster, stronger, or longer-lasting itch relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topical tripelennamine 1% cream (an antihistamine) compared to diphenhydramine 1% cream and a placebo cream base
What this could lead to
If tripelennamine cream proves more effective, it could offer a new option for treating itchy skin conditions.
What could go wrong
This is a small early-phase study in healthy volunteers, so results may not apply to real-world itching or lead to a marketable product.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

37 people

The number who actually took part.

Started

Feb 2025

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Pruritus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Palm Beach Atlantic University

    West Palm Beach, Florida, 33401, United States

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