Estrategias novedosas para reducir la cicatriz de quemaduras
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Celeste Finnerty, PhD
- Número de teléfono: 409-692-9036
- Correo electrónico: ccfinner@utmb.edu
Ubicaciones de estudio
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Texas
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Galveston, Texas, Estados Unidos, 77555
- Reclutamiento
- University of Texas Medical Branch, Galveston
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Contacto:
- Celeste Finnerty, PhD
- Número de teléfono: 409-692-9036
- Correo electrónico: ccfinner@utmb.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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) |
Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily. |
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Comparador de placebos: Placebo Group
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium. |
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Itch Scale: Visual Analogue Scale Itch (VAS Itch)
Periodo de tiempo: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Patient and Observer Scar Assessment Scale 3.0
Periodo de tiempo: baseline, and at clinic visit approximately 3 months (±15 days) after study start
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The Patient and Observer Scar Assessment Scale (POSAS) is an established scale for assessing scars by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. (POSAS 3.0) will be filled out by the participant and a clinical observer to evaluate scar severity/quality. |
baseline, and at clinic visit approximately 3 months (±15 days) after study start
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Brisbane Burn Scar Impact Panel (BBSIP)
Periodo de tiempo: baseline, and at clinic visit approximately 3 months (±15 days) after study start
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BBSIP is a patient-reported outcome measure developed in consultation with burn survivors that takes approximately 10 minutes to complete; the specificity of this comprehensive questionnaire allows detection of changes in quality of life related to burn hypertrophic scar. Higher scores indicate a worse outcome. |
baseline, and at clinic visit approximately 3 months (±15 days) after study start
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PROMIS-29
Periodo de tiempo: baseline, and at clinic visit approximately 3 months after study start (±15 days)
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This questionnaire will be administered to determine whether the effects of treatment impact quality of life as reported by the patient. |
baseline, and at clinic visit approximately 3 months after study start (±15 days)
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Pain scale: Visual Analog Scale for Pain (VAS Pain)
Periodo de tiempo: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
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The VAS pain score is a simple and effective method used to measure patients' pain levels. This method is typically represented by a line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain. Patients are asked to mark a point on the line that corresponds to their level of pain. |
baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
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Patient Global Impression of Change (PGIC)
Periodo de tiempo: baseline, and at clinic visit approximately 3 months after study start (±15 days)
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A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=not present, 2=mild, 3=moderate, 4=severe, and 5=very severe. A higher score indicates a worse outcome. |
baseline, and at clinic visit approximately 3 months after study start (±15 days)
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Participants Activity with Fitbit
Periodo de tiempo: Month 1, 2, 3 (+15 days, each timepoint)
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Overall activity: To be captured via Fitbit on a daily basis to gauge overall activity. These data will be correlated with the itch and pain scales, as reduced activity is associated with pain and/or itch. |
Month 1, 2, 3 (+15 days, each timepoint)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Celeste Finnerty, PhD, University of Texas Medical Branch, Galveston
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones de la piel
- Enfermedades de la piel
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Heridas y Lesiones
- Quemaduras
- Prurito
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Piranos
- Tiazoles
- Azoles
- Benzopirans
- Cromonas
- Famotidina
- Cromolín sódico
Otros números de identificación del estudio
- 24-0180
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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