Novel Strategies for Reducing Burn Scar Itch

September 18, 2025 updated by: The University of Texas Medical Branch, Galveston
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch, Galveston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all the inclusion criteria in order to be eligible to participate in the study.

  • 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:

Participants meeting any of the exclusion criteria at baseline will be excluded from study participation.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLUS Group
Treatment with active H1 antihistamine and administered active H2 antihistamine and using cromolyn sodium PLUS (-PLUS active H1 antihistamine, plus active famotidine and active cromolyn sodium)
Combination product: Famotidine and 4% topical cromolyn sodium
Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
Placebo Comparator: Placebo Group
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
Other: Placebo
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Itch Scale: Visual Analogue Scale Itch (VAS Itch)
Time Frame: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
Patients will score the severity of itch on the scale provided at study start, once weekly for 3 months, at the 3-month visit, and again at study end (6 months). Patients will rate their itch from 0 to 10. to measure the intensity of itchiness, where a patient marks a point on a line to indicate how severe their itch is, with zero representing "no itch" and 10 representing "worst imaginable itch." A higher score means a worse outcome.
baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS-29
Time Frame: baseline, and at clinic visit approximately 3 months after study start (±15 days)
This questionnaire will be administered to determine whether the effects of treatment impact quality of life as reported by the patient.
baseline, and at clinic visit approximately 3 months after study start (±15 days)
Pain scale: Visual Analog Scale for Pain (VAS Pain)
Time Frame: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
The VAS pain score is a simple and effective method used to measure patients' pain levels. This method is typically represented by a line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain. Patients are asked to mark a point on the line that corresponds to their level of pain.
baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
Patient Global Impression of Change (PGIC)
Time Frame: baseline, and at clinic visit approximately 3 months after study start (±15 days)
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=not present, 2=mild, 3=moderate, 4=severe, and 5=very severe. A higher score indicates a worse outcome.
baseline, and at clinic visit approximately 3 months after study start (±15 days)
Participants Activity with Fitbit
Time Frame: Month 1, 2, 3 (+15 days, each timepoint)
Overall activity: To be captured via Fitbit on a daily basis to gauge overall activity. These data will be correlated with the itch and pain scales, as reduced activity is associated with pain and/or itch.
Month 1, 2, 3 (+15 days, each timepoint)
The Patient and Observer Scar Assessment Scale 3.0
Time Frame: baseline, and at clinic visit approximately 3 months (±15 days) after study start
The Patient and Observer Scar Assessment Scale (POSAS) is an established scale for assessing scars by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. (POSAS 3.0) will be filled out by the participant and a clinical observer to evaluate scar severity/quality.
baseline, and at clinic visit approximately 3 months (±15 days) after study start
Brisbane Burn Scar Impact Panel (BBSIP)
Time Frame: baseline, and at clinic visit approximately 3 months (±15 days) after study start
BBSIP is a patient-reported outcome measure developed in consultation with burn survivors that takes approximately 10 minutes to complete; the specificity of this comprehensive questionnaire allows detection of changes in quality of life related to burn hypertrophic scar. Higher scores indicate a worse outcome.
baseline, and at clinic visit approximately 3 months (±15 days) after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

University of Texas

Investigators

  • Principal Investigator: Celeste Finnerty, PhD, University of Texas Medical Branch, Galveston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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