Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
15 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pharmacology Translational Unit
- Numéro de téléphone: 937-245-7500
- E-mail: pturesearch@docdermgroup.com
Lieux d'étude
-
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Ohio
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Fairborn, Ohio, États-Unis, 45324
- Wright State University - Pharmacology Translational Unit
-
Contact:
- Pharmacology Translational Unit
- Numéro de téléphone: 937-245-7500
- E-mail: pturesearch@docdermgroup.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Amitriptyline then Placebo
At Visit 1, subjects take 75mg amitriptyline.
Then at Visit 2, subjects take a placebo.
|
Placebo
75mg amitriptyline
|
|
Autre: Placebo then Amitriptyline
At Visit 1, subjects take placebo.
Then at Visit 2, subjects take 75mg amitriptyline.
|
Placebo
75mg amitriptyline
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2027
Achèvement primaire (Estimé)
1 juin 2033
Achèvement de l'étude (Estimé)
1 juin 2033
Dates d'inscription aux études
Première soumission
4 juin 2026
Première soumission répondant aux critères de contrôle qualité
4 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-2026-1023
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Oui
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