Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
Starting soon · Phase 1 · Has a placebo group
Conditions studied: Microvesicle Particles, Thermal Burn
In brief
The purpose of this study is to determine the amount of substances contained in skin known as microvesicle particles (MVP). The hypothesis to be tested in this study is that treatment with a single dose of 75mg of amitriptyline will block the MVP released from the skin from a very small localized burn injury.
Key facts
- Study ID
- NCT07640061
- Run by
- Wright State University
- People needed
- 20
- Starts
- 2027-06-01
- Expected to finish
- 2033-06-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult Males and Females age 18 - 60
- All skin types on Fitzpatrick Scale (Type I-VI)
- Able to comprehend procedures and risks
- Willing to participate and understand the informed consent document
- Have reliable transportation
You may not qualify if…
- Subjects should be otherwise healthy and not have any significant medical issues that could interfere with the study, in particular any heart arrythmias and not be on any prescription medications that could react with amitriptyline.
- 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 aSMase inhibitors
- Large tattoos in designated testing areas
- Tanning bed use within last 3 months
- UVB treatments in past 3 months
- Medical history of abnormal scarring or diseases that could affect wound healing
- Medical history of hypertension/hypotension or heart problems
- Pregnant or nursing
- History of sores in nares or easy bleeding from nares or other bleeding disorders.
- Nasal piercings
- 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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