About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Amitriptyline
Drug75mg amitriptyline
Placebo
DrugPlacebo
Treatment groups
Trial outcomes
Primary outcomes
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 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).
Secondary outcomes
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 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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