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

Conditions

• Amitriptyline
• Micorvesicle Particles

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• Amitriptyline — DRUG
  10% amitriptyline
• Placebo — OTHER
  Placebo

Study Details

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.

Key Dates

First listed

Jul 21, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2032

Completion

Jul 31, 2032

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• 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.

Primary Outcome Measure

To test if localized thermal burn injury will generate more microvesicle particles over untreated skin. [ Time Frame: 2 hours after the burn injury ]

Central Contacts

• Pharmacology Translational Unit
  937-245-7500
  [email protected]

Locations (1)

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