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

NCT07716722 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-2026-1027
• Study Type: interventional
• Target: 50
• 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). 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.

Conditions

Amitriptyline; Thermal Burn

Outcome Measures

Primary Outcomes (1)

• Change in the amount of microvesicle particles generated in skin from localized thermal burn injury 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 Outcomes (1)

• The amount of MVP released after topical 10% amitriptyline is provided immediately after localized thermal burn injury compared to vehicle.

  2 hours after the burn injury

Other Outcomes (1)

• The amount of MVP released after topical 10% amitriptyline is provided 5 and 15 minutes after localized thermal burn injury compared to vehicle and amitriptyline given immediately afterwards.

  2 hours after burn injury

Study Arms (1)

Heated Metal Bar to Skin

EXPERIMENTAL

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.

Drug: Amitriptyline; Other: Placebo

Interventions

Amitriptyline DRUG

10% amitriptyline

Heated Metal Bar to Skin

Placebo OTHER

Placebo

Heated Metal Bar to Skin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)