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

Part of paid clinical trials in Fairborn, Ohio.

Sponsor
Wright State University
Study ID
NCT07640061
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Microvesicle Particles
  • Thermal Burn

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Amitriptyline — DRUG
    75mg amitriptyline
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jun 30, 2027
Status verified
Jun 2026
Primary completion
Jun 30, 2033
Completion
Jun 30, 2033

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Other: Amitriptyline then Placebo
    At Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo.
  • Other: Placebo then Amitriptyline
    At Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline.

Primary Outcome Measure

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 [ Time Frame: 2 hours after the burn injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wright State University - Pharmacology Translational UnitFairbornOhio45324
Pharmacology Translational Unit
[email protected]
937-245-7500

Find similar trials in Fairborn, OH

By research site
Wright State University - Pharmacology Translational Unit· Fairborn, OH

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