Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release

Wright State University

Status and phase: Begins enrollment in 8 months; Phase 1

Conditions: Thermal Burn; Microvesicle Particles

Treatments: Drug: Amitriptyline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07640061

IRB-2026-1023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Amitriptyline then Placebo

Other group

Description:

At Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo.

Treatment:

Drug: Placebo

Drug: Amitriptyline

Placebo then Amitriptyline

Other group

Description:

At Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline.

Treatment:

Drug: Placebo

Drug: Amitriptyline