Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
15 de julio de 2026 actualizado por: Wright State University
The purpose of this study is to determine the amount of substances contained in skin known as microvesicle particles (MVP).
The hypothesis to be tested in this study is that treatment with a single dose of 75mg of amitriptyline will block the MVP released from the skin from a very small localized burn injury.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to determine the amount of substances contained in skin known as microvesicle particles (MVP).
Studies suggest these MVP are involved in many conditions such as after the thermal burn injury.
In fact, there is evidence suggesting that these MVP cause severe toxic effects and could be responsible for deaths following extensive thermal burn injuries.
These particles are typically found in skin and are evaluated by taking a portion of area with skin biopsy.
Of importance, MVP release from the skin can be blocked by drugs such as amitriptyline, a medicine which is a tricyclic anti-depressant.
The hypothesis to be tested in this study is that treatment with a single dose of 75mg of amitriptyline will block the MVP released from the skin from a very small localized burn injury.
This study is evaluating the amount of MVP made in the skin following a localized injury with heat and then conducting small skin biopsies.
Additionally, samples from the inside of the nostrils are collected.
By utilizing these methods after taking oral amitriptyline and then comparing them after taking a placebo, the investigator can see if taking the amitriptyline causes lesser amounts of MVP in the skin and nose cells.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pharmacology Translational Unit
- Número de teléfono: 937-245-7500
- Correo electrónico: pturesearch@docdermgroup.com
Ubicaciones de estudio
-
-
Ohio
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Fairborn, Ohio, Estados Unidos, 45324
- Wright State University - Pharmacology Translational Unit
-
Contacto:
- Pharmacology Translational Unit
- Número de teléfono: 937-245-7500
- Correo electrónico: pturesearch@docdermgroup.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Adult Males and Females age 18 - 60
- All skin types on Fitzpatrick Scale (Type I-VI)
- Able to comprehend procedures and risks
- Willing to participate and understand the informed consent document
- Have reliable transportation
Exclusion Criteria:
- Subjects should be otherwise healthy and not have any significant medical issues that could interfere with the study, in particular any heart arrythmias and not be on any prescription medications that could react with amitriptyline.
- History of abnormal scarring (i.e., keloids) or poor wound healing.
- No over the counter non-steroidal anti-inflammatory agents (aspirin, acetaminophen) or antioxidant vitamins (vitamin C) in past 14 days.
- Currently taking known photosensitizers, anti-inflammatories, other tricyclic antidepressants, or systemic agents known to be aSMase inhibitors
- Large tattoos in designated testing areas
- Tanning bed use within last 3 months
- UVB treatments in past 3 months
- Medical history of abnormal scarring or diseases that could affect wound healing
- Medical history of hypertension/hypotension or heart problems
- Pregnant or nursing
- History of sores in nares or easy bleeding from nares or other bleeding disorders.
- Nasal piercings
- Known allergies to lidocaine or amitriptyline
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Amitriptyline then Placebo
At Visit 1, subjects take 75mg amitriptyline.
Then at Visit 2, subjects take a placebo.
|
Placebo
75mg amitriptyline
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|
Otro: Placebo then Amitriptyline
At Visit 1, subjects take placebo.
Then at Visit 2, subjects take 75mg amitriptyline.
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Placebo
75mg amitriptyline
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in MVP Release in Skin from a localized thermal burn injury in response to oral amitriptyline versus placebo as measured by skin biopsy
Periodo de tiempo: 2 hours after the burn injury
|
To see the change from baseline in microvesicle particle release in the skin after a localized thermal burn injury.
In this double-blinded placebo-controlled crossover study.
Subjects are treated with placebo or 75mg amitriptyline and 90 minutes later a small area of anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury.
Skin biopsies of burned and nearby untreated area will be obtained 2 hours after localized burn injury.
MVP will be measured int he tissue.
Briefly, the biopsies will be weighed, and treated with enzymes to break down the tissue.
Following several centrifugation steps, the MVP fraction will be measured using a Nanosight instrument.
The MVPs will be normalized to biopsy weight.
The process will be repeated in 6-10 weeks but will use opposite forearm and subjects who were given placebo will be given amitriptyline (and vice versa).
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2 hours after the burn injury
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in MVP release of nasal mucosal cells obtained from one nostril before and other nostril 90 min after subject ingests placebo or 75mg amitriptyline
Periodo de tiempo: 2 hours after burn injury
|
These studies will test if oral amitriptyline will block thermal injury-induced MVP release in nasal epithelial cells ex vivo.
Subjects will have nasal epithelial cells removed from one nostril before and other nostril 90 minutes following treatment with placebo or 75mg amitriptyline.
The nasal mucosal epithelial cells will taken to the laboratory and treated with a 30 second exposure to a heated water bath and 2 hours later MVP isolated from the supernatants and following several centrifugation steps, the MVP fraction will be quantitated using a Nanosight instrument.
The process will be repeated in 6-10 weeks but subjects who were given placebo will be given amitriptyline (and vice versa).
The amount of MVP induced in the supernatants of nasal mucosa cells treated with burn injury ex vivo will be compared to no burn treatment.
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2 hours after burn injury
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2027
Finalización primaria (Estimado)
1 de junio de 2033
Finalización del estudio (Estimado)
1 de junio de 2033
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-2026-1023
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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