Novel Strategies for Reducing Burn Scar Itch

NCT06801626 | Recruiting Phase 3 DMC

• 1 other identifier: 24-0180
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Itch; Burn; Diphenhydramine; Famotidine

Outcome Measures

Primary Outcomes (1)

• Itch Scale: Visual Analogue Scale Itch (VAS Itch)

  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 Outcomes (6)

• The Patient and Observer Scar Assessment Scale 3.0

  baseline, and at clinic visit approximately 3 months (±15 days) after study start

• Brisbane Burn Scar Impact Panel (BBSIP)

  baseline, and at clinic visit approximately 3 months (±15 days) after study start

• PROMIS-29

  baseline, and at clinic visit approximately 3 months after study start (±15 days)

• Pain scale: Visual Analog Scale for Pain (VAS Pain)

  baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)

• Patient Global Impression of Change (PGIC)

  baseline, and at clinic visit approximately 3 months after study start (±15 days)

Study Arms (2)

PLUS Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

PLUS Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• University of Texas: collaborator

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Pruritus; Burns

Interventions

Famotidine; Cromolyn Sodium

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Celeste Finnerty, PhD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Allen, RN

CONTACT

409-266-2678; listurm@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)