Novel Strategies for Reducing Burn Scar Itch
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Famotidine and 4% topical cromolyn sodium, Placebo.
- Who it may be relevant to
- Registry conditions: Burn Scar, Itch Scarring, Wound. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product 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. - Other Placebo
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- The Patient and Observer Scar Assessment Scale 3.0 [Time frame: baseline, and at clinic visit approximately 3 months (±15 days) after study start]
- Brisbane Burn Scar Impact Panel (BBSIP) [Time frame: baseline, and at clinic visit approximately 3 months (±15 days) after study start]
- PROMIS-29 [Time frame: baseline, and at clinic visit approximately 3 months after study start (±15 days)]
- Pain scale: Visual Analog Scale for Pain (VAS Pain) [Time frame: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)]
- Patient Global Impression of Change (PGIC) [Time frame: baseline, and at clinic visit approximately 3 months after study start (±15 days)]
- Participants Activity with Fitbit [Time frame: Month 1, 2, 3 (+15 days, each timepoint)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Medical Branch, Galveston — Galveston
Identifiers
NCT: NCT06801626 · 24-0180