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

This study is investigating how a small burn injury affects tiny particles in your skin called microvesicle particles (MVPs). Researchers believe MVPs are involved in how skin responds to injuries like burns. They want to see if applying a medication called amitriptyline to the skin can prevent these MVPs from increasing after a burn. You might be able to join if you are an adult between 18 and 64 years old with any skin type, and do not have conditions that affect wound healing or a history of abnormal scarring. The study will compare amitriptyline to a placebo (an inactive substance). The main goal is to see if a burn injury increases MVPs in the skin. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. It will compare the effects of 10% amitriptyline to a placebo.
What's involved
You would receive a small burn injury, and then either amitriptyline or a placebo would be applied. Skin biopsies would be taken to measure MVPs.
Compensation
Not stated in the trial record.
Follow-up
MVPs will be measured at 2 hours after the burn injury.

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NCT07716722

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

Not Yet Recruiting
PHASE1Ages 18–64InterventionalPrevention
Wright State University
~50 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:AmitriptylinePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the amount of microvesicle particles generated in skin from localized thermal burn injury over untreated skin.
Measured over 2 hours after the burn injury
Thermal Burn
Amitriptyline
1 sites across 1 states
Ohio1

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Eligibility criteria

Inclusion

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

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