Clinical trial NCT06801626: Novel Strategies for Reducing Burn Scar Itch
Official title: Novel Strategies for Reducing Burn Scar Itch
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Burn Scar
Itch Scarring
Wound
Keywords: Itch
Burn
Diphenhydramine
Famotidine
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2025-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Itch Scale: Visual Analogue Scale Itch (VAS Itch)
timeFrame: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
Secondary outcomes:
measure: The Patient and Observer Scar Assessment Scale 3.0
timeFrame: baseline, and at clinic visit approximately 3 months (±15 days) after study start
measure: Brisbane Burn Scar Impact Panel (BBSIP)
timeFrame: baseline, and at clinic visit approximately 3 months (±15 days) after study start
measure: PROMIS-29
timeFrame: baseline, and at clinic visit approximately 3 months after study start (±15 days)
measure: Pain scale: Visual Analog Scale for Pain (VAS Pain)
timeFrame: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
measure: Patient Global Impression of Change (PGIC)
timeFrame: baseline, and at clinic visit approximately 3 months after study start (±15 days)
measure: Participants Activity with Fitbit
timeFrame: Month 1, 2, 3 (+15 days, each timepoint)
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Galveston
state: Texas
Study officials:
affiliation: University of Texas Medical Branch, Galveston
name: Celeste Finnerty, PhD
role: PRINCIPAL_INVESTIGATOR
References: