Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline

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. These particles are typically found in skin and are evaluated by taking a portion of area with skin biopsy. The hypothesis to be tested is that people treated with a small burn injury will result in MVP levels and that this can be blocked by applying the drug amitriptyline to the area. The topical amitriptyline will be given either immediately after the burn, or at a short time afterwards (5 or 15 minutes). Skin biopsies of the areas will be taken and the study team will measure the MVPs in the skin. By utilizing these methods the study team can determine if there are differences in the numbers of MVP made following a small thermal burn injury and if this can be blocked by topical treatment with amitriptyline.

Study Overview

• Status: Not yet recruiting
• Conditions: Amitriptyline; Micorvesicle Particles
• Intervention / Treatment: Other: Placebo; Drug: Amitriptyline

• Study Type: Interventional
• Enrollment (Estimated): 50
• 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/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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Heated Metal Bar to Skin; Five small areas on the inner forearms will be selected for treatment. Three of the areas will be treated with the heated metal bar and 10% amitriptyline is applied immediately after the burn, 5 minutes after the burn and 15 minutes after the burn. One of the selected area will be treated with the heated metal bar then a placebo will be applied. Also, placebo will be applied to one area that is not treated with the metal bar.

Other: Placebo; Placebo; Drug: Amitriptyline; 10% amitriptyline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test if localized thermal burn injury will generate more microvesicle particles over untreated skin.	Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied. Vehicle will also be applied to nearby un-burned skin. Skin biopsies of burned provided vehicle and nearby unburned area with vehicle will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in untreated skin will be compared to skin which underwent a thermal burn injury.	2 hours after the burn injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test if topical 10% amitriptyline provided immediately after localized thermal burn injury will block MVP release compared to vehicle.	Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied to one burned area and 10% amitriptyline will be applied to the other burned site. Skin biopsies of burned provided and nearby untreated area will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in skin treated with vehicle + burn injury will be compared to skin treated with amitriptyline + burn injury to ascertain if the amitriptyline can decrease the burn-induced MVP release.	2 hours after the burn injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test if topical 10% amitriptyline provided 5 and 15 minutes after localized thermal burn injury will block MVP release compared to vehicle and amitriptyline given immediately afterwards.	Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate thermal burn injuries in two sites. 0.1 mL of 10% amitriptyline will be applied to one burned site 5 minutes after the burn injury and 10% amitriptyline will be applied at 15 minutes post-burn injury at 15 minutes. Skin biopsies of sites will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in skin treated with vehicle + burn injury will be compared to skin treated with amitriptyline + burn injury at various times post-treatment to ascertain if the amitriptyline can decrease the burn-induced MVP release, and if amitriptyline is still effective if given 5 and 15 minutes post burn injury.	2 hours after burn injury

Collaborators and Investigators

• Sponsor: Wright State University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 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-2026-1027

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