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

NCT07716722 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-30

No results posted yet for this study

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

  • Thermal Burn
  • Amitriptyline

Interventions

DRUG

Amitriptyline

10% amitriptyline

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Wright State University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2032-07-31
Completion
2032-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716722 on ClinicalTrials.gov