Recruiting
Phase 3

Burn Scar Itch

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06801626

Conditions

Burn Scar

Itch Scarring

Wound

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Famotidine and 4% topical cromolyn sodium

Placebo

Study Details

Brief summary:

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

Conditions

Burn Scar

Itch Scarring

Wound

Study ID

NCT06801626

Start date

Mar 1, 2025

Status verified date

Sep, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

placebo comparator: Placebo Group

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

Interventions

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Celeste Finnerty, PhD

409-692-9036ccfinner@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • Itch
  • Burn
  • Diphenhydramine
  • Famotidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-09-24.