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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorWright State University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amitriptyline
  • Placebo

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators