Pilot Studies Testing the Use of Oral Amitriptyline in Reducing Localized Burn Injury-induced Microvesicle Particle Release
2026年7月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Pharmacology Translational Unit
- 電話番号：937-245-7500
- メール：pturesearch@docdermgroup.com
研究場所
-
-
Ohio
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Fairborn、Ohio、アメリカ、45324
- Wright State University - Pharmacology Translational Unit
-
コンタクト：
- Pharmacology Translational Unit
- 電話番号：937-245-7500
- メール：pturesearch@docdermgroup.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Amitriptyline then Placebo
At Visit 1, subjects take 75mg amitriptyline.
Then at Visit 2, subjects take a placebo.
|
プラセボ
75mg amitriptyline
|
|
他の：Placebo then Amitriptyline
At Visit 1, subjects take placebo.
Then at Visit 2, subjects take 75mg amitriptyline.
|
プラセボ
75mg amitriptyline
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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).
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2 hours after the burn injury
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年6月1日
一次修了 (推定)
2033年6月1日
研究の完了 (推定)
2033年6月1日
試験登録日
最初に提出
2026年6月4日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-2026-1023
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。