Microvesicle ParticlesPhase 1NCT07640061
Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
A Phase 1 study testing Amitriptyline in people with Microvesicle Particles and Thermal Burn, run by Wright State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microvesicle Particles, Thermal Burn
- What is being tested?
- Amitriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Jun 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wright State University - Pharmacology Translational Unit
Fairborn, Ohio, 45324
Pharmacology Translational Unit, 937-245-7500, pturesearch@docdermgroup.com
About this study
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.
Read the detailed description
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. In fact, there is evidence suggesting that these MVP cause severe toxic effects and could be responsible for deaths following extensive thermal burn injuries. These particles are typically found in skin and are evaluated by taking a portion of area with skin biopsy. Of importance, MVP release from the skin can be blocked by drugs such as amitriptyline, a medicine which is a tricyclic anti-depressant. 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. This study is evaluating the amount of MVP made in the skin following a localized injury with heat and then conducting small skin biopsies. Additionally, samples from the inside of the nostrils are collected. By utilizing these methods after taking oral amitriptyline and then comparing them after taking a placebo, the investigator can see if taking the amitriptyline causes lesser amounts of MVP in the skin and nose cells.
- Conditions
- Microvesicle Particles, Thermal Burn
- Being tested
- Amitriptyline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
75mg amitriptyline
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline then Placebo | Other | At Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo. Receives: Drug: Amitriptyline; Drug: Placebo |
| Placebo then Amitriptyline | Other | At Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline. Receives: Drug: Amitriptyline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in MVP Release in Skin from a localized thermal burn injury in response to oral amitriptyline versus placebo as measured by skin biopsy
To see the change from baseline in microvesicle particle release in the skin after a localized thermal burn injury. In this double-blinded placebo-controlled crossover study. Subjects are treated with placebo or 75mg amitriptyline and 90 minutes later a small area of anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Skin biopsies of burned and nearby untreated area will be obtained 2 hours after localized burn injury. MVP will be measured int he tissue. Briefly, the biopsies will be weighed, and treated with enzymes to break down the tissue. Following several centrifugation steps, the MVP fraction will be measured using a Nanosight instrument. The MVPs will be normalized to biopsy weight. The process will be repeated in 6-10 weeks but will use opposite forearm and subjects who were given placebo will be given amitriptyline (and vice versa).
Measured: 2 hours after the burn injury
Secondary outcomes (1)
Change in MVP release of nasal mucosal cells obtained from one nostril before and other nostril 90 min after subject ingests placebo or 75mg amitriptyline
These studies will test if oral amitriptyline will block thermal injury-induced MVP release in nasal epithelial cells ex vivo. Subjects will have nasal epithelial cells removed from one nostril before and other nostril 90 minutes following treatment with placebo or 75mg amitriptyline. The nasal mucosal epithelial cells will taken to the laboratory and treated with a 30 second exposure to a heated water bath and 2 hours later MVP isolated from the supernatants and following several centrifugation steps, the MVP fraction will be quantitated using a Nanosight instrument. The process will be repeated in 6-10 weeks but subjects who were given placebo will be given amitriptyline (and vice versa). The amount of MVP induced in the supernatants of nasal mucosa cells treated with burn injury ex vivo will be compared to no burn treatment.
Measured: 2 hours after burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvesicle ParticlesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At the first visit, Visit 1 subjects will be assigned to take amitriptyline or placebo. Then at Visit 2, subjects will be assigned to the treatment they were not assigned to at Visit 1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640061
- Sponsor's protocol ID
- IRB-2026-1023
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
- ClinicalTrials.gov ID
- NCT07640061
- Acronym / sponsor ID
- IRB-2026-1023
- Conditions
- Microvesicle Particles, Thermal Burn
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. In fact, there is evidence suggesting that these MVP cause severe toxic effects and could be responsible for deaths following extensive thermal burn injuries. These particles are typically found in skin and are evaluated by taking a portion of area with skin biopsy. Of importance, MVP release from the skin can be blocked by drugs such as amitriptyline, a medicine which is a tricyclic anti-depressant. 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. This study is evaluating the amount of MVP made in the skin following a localized injury with heat and then conducting small skin biopsies. Additionally, samples from the inside of the nostrils are collected. By utilizing these methods after taking oral amitriptyline and then comparing them after taking a placebo, the investigator can see if taking the amitriptyline causes lesser amounts of MVP in the skin and nose cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- At the first visit, Visit 1 subjects will be assigned to take amitriptyline or placebo. Then at Visit 2, subjects will be assigned to the treatment they were not assigned to at Visit 1.
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline then Placebo | Other | Drug: Amitriptyline, Drug: PlaceboAt Visit 1, subjects take 75mg amitriptyline. Then at Visit 2, subjects take a placebo. |
| Placebo then Amitriptyline | Other | Drug: Amitriptyline, Drug: PlaceboAt Visit 1, subjects take placebo. Then at Visit 2, subjects take 75mg amitriptyline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amitriptyline75mg amitriptyline | Drug | Amitriptyline then Placebo, Placebo then Amitriptyline |
| PlaceboPlacebo | Drug | Amitriptyline then Placebo, Placebo then Amitriptyline |
Primary outcome
Change from Baseline in MVP Release in Skin from a localized thermal burn injury in response to oral amitriptyline versus placebo as measured by skin biopsy
Time frame: 2 hours after the burn injury
To see the change from baseline in microvesicle particle release in the skin after a localized thermal burn injury. In this double-blinded placebo-controlled crossover study. Subjects are treated with placebo or 75mg amitriptyline and 90 minutes later a small area of anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Skin biopsies of burned and nearby untreated area will be obtained 2 hours after localized burn injury. MVP will be measured int he tissue. Briefly, the biopsies will be weighed, and treated with enzymes to break down the tissue. Following several centrifugation steps, the MVP fraction will be measured using a Nanosight instrument. The MVPs will be normalized to biopsy weight. The process will be repeated in 6-10 weeks but will use opposite forearm and subjects who were given placebo will be given amitriptyline (and vice versa).
1 secondary outcome
Change in MVP release of nasal mucosal cells obtained from one nostril before and other nostril 90 min after subject ingests placebo or 75mg amitriptyline
Time frame: 2 hours after burn injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for Microvesicle Particles
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Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Photosensitivity, Microvesicle Particle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amitriptyline in people with Microvesicle Particles and Thermal Burn, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pharmacology Translational Unit (937-245-7500, pturesearch@docdermgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in MVP Release in Skin from a localized thermal burn injury in response to oral amitriptyline versus placebo as measured by skin biopsy (time frame: 2 hours after the burn injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.