Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
15 juli 2026 uppdaterad av: Wright State University
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Pharmacology Translational Unit
- Telefonnummer: 937-245-7500
- E-post: pturesearch@docdermgroup.com
Studieorter
-
-
Ohio
-
Fairborn, Ohio, Förenta staterna, 45324
- Wright State University - Pharmacology Translational Unit
-
Kontakt:
- Pharmacology Translational Unit
- Telefonnummer: 937-245-7500
- E-post: pturesearch@docdermgroup.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Amitriptyline then Placebo
At Visit 1, subjects take 75mg amitriptyline.
Then at Visit 2, subjects take a placebo.
|
Placebo
75mg amitriptyline
|
|
Övrig: Placebo then Amitriptyline
At Visit 1, subjects take placebo.
Then at Visit 2, subjects take 75mg amitriptyline.
|
Placebo
75mg amitriptyline
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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).
|
2 hours after the burn injury
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 2 hours after burn injury
|
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.
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2 hours after burn injury
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2027
Primärt slutförande (Beräknad)
1 juni 2033
Avslutad studie (Beräknad)
1 juni 2033
Studieregistreringsdatum
Först inskickad
4 juni 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
10 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juli 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-2026-1023
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
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