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NCT Number: NCT06801626

Novel Strategies for Reducing Burn Scar Itch

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location status: Recruiting

Location contact

Celeste Finnerty, PhD

CONTACT

[email protected]

409-692-9036

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famotidine and 4% topical cromolyn sodium

Combination Product

Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.

Placebo

Other

Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsey Allen, RN

CONTACT

[email protected]

409-266-2678

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • University of Texas

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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