Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amitriptyline, Placebo.
- Who it may be relevant to
- Registry conditions: Thermal Burn, Amitriptyline. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Amitriptyline
10% amitriptyline - Other Placebo
Placebo
Primary outcome measures
- Change in the amount of microvesicle particles generated in skin from localized thermal burn injury over untreated skin. [Time frame: 2 hours after the burn injury]
Secondary outcome measures (1)
- The amount of MVP released after topical 10% amitriptyline is provided immediately after localized thermal burn injury compared to vehicle. [Time frame: 2 hours after the burn injury]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wright State University - Pharmacology Translational Unit — Fairborn
Identifiers
NCT: NCT07716722 · IRB-2026-1027