Topical Tripelennamine 1% Cream Versus Diphenhydramine 1% Cream for the Relief of Histamine-Induced Itching: A Proof Concept Study in Healthy Adults.
Public ClinicalTrials.gov record NCT07778472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07778472
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 23, 2025
- Primary completion
- Sep 17, 2025
- Completion
- Sep 17, 2025
- Last update posted
- Aug 20, 2026
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Palm Beach Atlantic University | West Palm Beach | Florida | 33401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07778472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07778472 live on ClinicalTrials.gov.