Novel Strategies for Reducing Burn Scar Itch

Обзор

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

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.
• Другое Placebo
  Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Первичные конечные точки

• Itch Scale: Visual Analogue Scale Itch (VAS Itch) [Срок оценки: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date]

Вторичные конечные точки (6)

• The Patient and Observer Scar Assessment Scale 3.0 [Срок оценки: baseline, and at clinic visit approximately 3 months (±15 days) after study start]
• Brisbane Burn Scar Impact Panel (BBSIP) [Срок оценки: baseline, and at clinic visit approximately 3 months (±15 days) after study start]
• PROMIS-29 [Срок оценки: baseline, and at clinic visit approximately 3 months after study start (±15 days)]
• Pain scale: Visual Analog Scale for Pain (VAS Pain) [Срок оценки: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)]
• Patient Global Impression of Change (PGIC) [Срок оценки: baseline, and at clinic visit approximately 3 months after study start (±15 days)]
• Participants Activity with Fitbit [Срок оценки: Month 1, 2, 3 (+15 days, each timepoint)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas Medical Branch, Galveston — Galveston

Идентификаторы

NCT: NCT06801626 · 24-0180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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