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Can a common antidepressant cream stop Burn-Induced cellular 'Debris'?

NCT ID NCT07716722

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study investigates whether a topical cream containing amitriptyline, a drug typically used for depression and pain, can block the release of microvesicle particles (MVPs) from skin after a small thermal burn. Healthy adults aged 18-64 receive a tiny, controlled burn on their forearm, and the cream is applied immediately or shortly after. Skin biopsies are taken to measure MVP levels, comparing treated and untreated areas.

What this could mean

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

Active substance
a topical cream containing 10% amitriptyline
What this could lead to
If successful, this could point toward a way to reduce harmful inflammatory particles released after skin injuries like burns.
What could go wrong
This is a very early pilot study with only 50 participants, so results may not apply to larger or more severe injuries. The drug is tested on tiny, controlled burns, not real-world wounds.

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 50 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2032

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 64 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/Females ages 18-64 * All skin types on Fitzpatrick Scale (Type I-VI) * Able to comprehend procedures and risks * Must be able to give informed consent Exclusion Criteria: * Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus) * 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 ASM inhibitors * Large tattoos in designated testing areas * Tanning bed use within last 3 months * UVB treatments in past 3 months * Pregnant or nursing * 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.

Amitriptyline Micorvesicle particles Thermal burn

How to take part

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  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

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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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