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NOT YET RECRUITING
NCT07716722
PHASE1

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

Sponsor: Wright State University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07

Completion Date

2032-07

Last Updated

2026-07-21

Healthy Volunteers

Yes

Interventions

DRUG

Amitriptyline

10% amitriptyline

OTHER

Placebo

Placebo

Locations (1)

Wright State University - Pharmacology Translational Unit

Fairborn, Ohio, United States