Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
Starting soon · Phase 1 · Has a placebo group
Conditions studied: Thermal Burn, Amitriptyline
In brief
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 facts
- Study ID
- NCT07716722
- Run by
- Wright State University
- People needed
- 50
- Starts
- 2026-07-01
- Expected to finish
- 2032-07-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Large tattoos in designated testing areas
- Tanning bed use within last 3 months
- UVB treatments in past 3 months
- Pregnant or nursing
- Known allergies to lidocaine or amitriptyline
Where it is running
- Wright State University - Pharmacology Translational Unit — Fairborn, Ohio, United States
Full record on ClinicalTrials.gov
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