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Novel Strategies for Reducing Burn Scar Itch | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Novel Strategies for Reducing Burn Scar Itch

NCT06801626•The University of Texas Medical Branch, Galveston

Summary

The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.

Detailed Description

The purpose of this study is to examine the effect of a new approach to treating burn scar itch. In other patient populations experiencing itch, H2 antihistamines and/or topically applied cromolyn sodium have decreased itch. We believe that these medications will reduce itch from burn scars. To test this idea, the investigators will compare two methods of treating itch: 1) recommended oral diphenhydramine (Benadryl) with placebo capsule and placebo lotion and 2) recommended oral diphenhydramine (Benadryl) with administration of oral famotidine (Pepcid) and topically applied cromolyn sodium.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
•Adults: ≥18 to \<80 years of age.
•Has an itchy burn scar.

Exclusion Criteria

•Failure to obtain consent or unable to return for follow up assessments.
•Patient is unable to follow the protocol required assessments.
•Member of a vulnerable class (e.g., prisoners, pregnant participant, etc.).
•Any medical condition that, in the opinion of the investigator or physician, would place the participant at increased risk for participation.
•Concurrent participation in another interventional clinical trial (to avoid confounding factors that may influence outcomes).
•History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the participant to comply with the study procedures or follow the investigators instructions.
•Age \< 18 or ≥ 80 years.
•Taking one of the following medications: cefuroxime, dasatinib, delavirdine, neratinib, pazopanib, risedronate, or tizanidine.
•Has a pre-existing inflammatory or itchy skin disease.
•Is taking an H2 antihistamine for another indication.

Locations (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

November 1, 2027

Last Updated

September 24, 2025

Enrollment

ESTIMATED participants

Conditions

Burn ScarItch ScarringWound

Interventions

Famotidine and 4% topical cromolyn sodium

COMBINATION_PRODUCT

Placebo

OTHER

Contacts

Lindsey Allen, RN

CONTACT

409-266-2678 listurm@utmb.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Novel Strategies for Reducing Burn Scar Itch

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