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Could pepcid and a skin lotion finally stop burn scar itching?

NCT ID NCT06801626

Symptom relief Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of famotidine (Pepcid) pills and cromolyn sodium lotion can reduce itching from burn scars. 44 adults with itchy burn scars will take either the active combo or a placebo (plus a standard antihistamine) for 6 months. The main goal is to see if itch severity drops, measured by a simple 0-10 scale.

What this could mean

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

Active substance
Famotidine (Pepcid) and 4% cromolyn sodium lotion
What this could lead to
If it works, this could offer a new, effective way to reduce chronic itching from burn scars, improving quality of life.
What could go wrong
This is a small Phase 3 trial (44 people) and results may not apply to everyone. Itching is subjective, and the placebo group also gets an active antihistamine, so the added benefit of the study drugs may be modest.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

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 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 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.

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Conditions

The condition(s) this trial relates to.

burn injury Pruritus

As listed by the trial registrant

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

Burn scar Itch scarring Wound

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Medical Branch, Galveston

    RECRUITING

    Galveston, Texas, 77555, United States

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