Thermal BurnPhase 1NCT07716722
Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
A Phase 1 study testing Amitriptyline in people with Thermal Burn and Amitriptyline, 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). Studies suggest these MVP are involved in many conditions such as after the thermal burn injury. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermal Burn, Amitriptyline
- What is being tested?
- Amitriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2032
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- UVB treatments in past 3 months
- Pregnant or nursing
- 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). 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.
- Conditions
- Thermal Burn, Amitriptyline
- Being tested
- Amitriptyline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
10% amitriptyline
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Heated Metal Bar to Skin | Experimental | Five small areas on the inner forearms will be selected for treatment. Three of the areas will be treated with the heated metal bar and 10% amitriptyline is applied immediately after the burn, 5 minutes after the burn and 15 minutes after the burn. One of the selected area will be treated with the heated metal bar then a placebo will be applied. Also, placebo will be applied to one area that is not treated with the metal bar. Receives: Drug: Amitriptyline; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of microvesicle particles generated in skin from localized thermal burn injury over untreated skin.
Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied. Vehicle will also be applied to nearby un-burned skin. Skin biopsies of burned provided vehicle and nearby unburned area with vehicle will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in untreated skin will be compared to skin which underwent a thermal burn injury.
Measured: 2 hours after the burn injury
Secondary outcomes (1)
The amount of MVP released after topical 10% amitriptyline is provided immediately after localized thermal burn injury compared to vehicle.
Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied to one burned area and 10% amitriptyline will be applied to the other burned site. Skin biopsies of burned provided and nearby untreated area will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in skin treated with vehicle + burn injury will be compared to skin treated with amitriptyline + burn injury to ascertain if the amitriptyline can decrease the burn-induced MVP release.
Measured: 2 hours after the burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07716722
- Sponsor's protocol ID
- IRB-2026-1027
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Blocking Injury-Induced MVP Release in Skin Using Topical Amitriptyline
- ClinicalTrials.gov ID
- NCT07716722
- Acronym / sponsor ID
- IRB-2026-1027
- Conditions
- Thermal Burn, Amitriptyline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 21 Jul 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). 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heated Metal Bar to Skin | Experimental | Drug: Amitriptyline, Other: PlaceboFive small areas on the inner forearms will be selected for treatment. Three of the areas will be treated with the heated metal bar and 10% amitriptyline is applied immediately after the burn, 5 minutes after the burn and 15 minutes after the burn. One of the selected area will be treated with the heated metal bar then a placebo will be applied. Also, placebo will be applied to one area that is not treated with the metal bar. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Amitriptyline10% amitriptyline | Drug | Heated Metal Bar to Skin |
| PlaceboPlacebo | Other | Heated Metal Bar to Skin |
Primary outcome
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
Anesthetized volar forearm skin will be treated with a heated 3.5 mm metal rod to generate a thermal burn injury. Immediately after the burn injury 0.1mL of polyethylene glycol vehicle will be applied. Vehicle will also be applied to nearby un-burned skin. Skin biopsies of burned provided vehicle and nearby unburned area with vehicle will be obtained 2 hours after localized burn injury. MVP will be measured. 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 numbers of MVP in untreated skin will be compared to skin which underwent a thermal burn injury.
1 secondary outcome
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
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 30 Sep 2026.
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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 Thermal Burn and Amitriptyline, 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 4 inclusion and 9 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 30 Sep 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 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). 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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.