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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
75mg amitriptyline
Placebo
Wright State University - Pharmacology Translational Unit
Fairborn, Ohio, United States
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
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. 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).
Time frame: 2 hours after the burn injury
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
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 and measured. The process will be repeated in 6-10 weeks but subjects who were given placebo will be given amitriptyline (and vice versa).
Time frame: 2 hours after burn injury
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