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NCT07640061

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

Not Yet Recruiting
PHASE1Ages 18–60InterventionalPrevention
Wright State University
~20 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:AmitriptylinePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 2 hours after the burn injury

Conditions

Microvesicle Particles
Thermal Burn

Explore related trials

Thermal Burn

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Pharmacology Translational Unit
[email protected]
937-245-7500
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 biopsy2 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).