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

NCT07640061 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-2026-1023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microvesicle Particles; Thermal Burn

Outcome Measures

Primary Outcomes (1)

• 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).

  2 hours after the burn injury

Secondary Outcomes (1)

• 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

  2 hours after burn injury

Study Arms (2)

Amitriptyline then Placebo

OTHER

At Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo.

Drug: Amitriptyline; Drug: Placebo

Placebo then Amitriptyline

OTHER

At Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline.

Drug: Amitriptyline; Drug: Placebo

Interventions

Placebo DRUG

Placebo

Amitriptyline then Placebo; Placebo then Amitriptyline

Amitriptyline DRUG

75mg amitriptyline

Amitriptyline then Placebo; Placebo then Amitriptyline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State University - Pharmacology Translational Unit

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Interventions

Amitriptyline

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Pharmacology Translational Unit

CONTACT

937-245-7500; pturesearch@docdermgroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At the first visit, Visit 1 subjects will be assigned to take amitriptyline or placebo. Then at Visit 2, subjects will be assigned to the treatment they were not assigned to at Visit 1.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: July 17, 2026

Record last verified: 2026-06

Locations

US (1)