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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thermal Burn; Microvesicle Particles
• Intervention / Treatment: Drug: Placebo; Drug: Amitriptyline

Detailed Description

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
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pharmacology Translational Unit; Phone Number: 937-245-7500; Email: pturesearch@docdermgroup.com

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State University - Pharmacology Translational Unit
      • Contact: Pharmacology Translational Unit; Phone Number: 937-245-7500; Email: pturesearch@docdermgroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Amitriptyline then Placebo; At Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo.	Drug: Placebo; Placebo; Drug: Amitriptyline; 75mg amitriptyline
Other: Placebo then Amitriptyline; At Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline.	Drug: Placebo; Placebo; Drug: Amitriptyline; 75mg amitriptyline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 hours after the burn injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 hours after burn injury

Collaborators and Investigators

• Sponsor: Wright State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Amitriptyline
• Other Study ID Numbers: IRB-2026-1023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes