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NCT Number: NCT07716722

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.

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Key information

Conditions

Thermal Burn Amitriptyline

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wright State University - Pharmacology Translational Unit

Fairborn, Ohio, 45324, United States

Location contact

Pharmacology Translational Unit

CONTACT

[email protected]

937-245-7500

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amitriptyline

Drug

10% amitriptyline

Placebo

Other

Placebo

Primary outcomes

  1. Change in the amount of microvesicle particles generated in skin from localized thermal burn injury over untreated skin.

    Time frame: 2 hours after the burn injury

    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.

Secondary outcomes

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

    Time frame: 2 hours after the burn injury

    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.

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.

    Time frame: 2 hours after burn injury

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pharmacology Translational Unit

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 21, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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