Novel Strategies for Reducing Burn Scar Itch

NCT ID: NCT06801626

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-11-01

Brief 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.

Conditions

Burn Scar; Itch Scarring; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Famotidine and 4% topical cromolyn sodium

Intervention Type: 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 Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celeste Finnerty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsey Allen, RN

Role: CONTACT

listurm@utmb.edu

409-266-2678

Facility Contacts

Celeste Finnerty, PhD

Role: primary

ccfinner@utmb.edu

409-692-9036

Other Identifiers

24-0180

Identifier Type: -

Identifier Source: org_study_id