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Can a common antidepressant calm burn damage? early study investigates

NCT ID NCT07640061

Knowledge-focused Sponsor: Wright State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This pilot study tests whether a single 75mg dose of amitriptyline can reduce the release of microvesicle particles (tiny substances) from skin after a very small, controlled burn. Twenty healthy adults will receive either amitriptyline or a placebo, then a small heated rod creates a minor burn on their forearm. Skin samples will be taken to measure particle release. The study aims to understand the body's response to injury, not to treat burns directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amitriptyline
What this could lead to
If it works, this could point toward a way to reduce harmful particles released after burns, potentially improving healing.
What could go wrong
This is a very early, small pilot study with only 20 people. It tests a tiny controlled burn, not real-world injuries, and may not translate to actual burn care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

burn

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microvesicle particles Thermal burn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Wright State University - Pharmacology Translational Unit

    Fairborn, Ohio, 45324, United States

    Contact Email: •••••@•••••

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