Идёт набор NCT06778434

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Фаза II С лечением Actinic Keratosis Imipramine Photodynamic Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Imipramine, Control Vehicle.
Кому может быть актуально: Состояния в реестре: Actinic Keratosis, Imipramine, Photodynamic Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans

Обзор

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.

Вмешательства

Препарат Imipramine
10% imipramine
Другое Control Vehicle
polyethylene glycol: dimethyl sulfoxide Solution

Первичные конечные точки

(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine [Срок оценки: 7, 30, 90 days post-PDT treatments]
(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine [Срок оценки: 7, 30, 90 days post-PDT treatments]
Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face [Срок оценки: 6, 12 months post-PDT treatment]

Вторичные конечные точки (4)

Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms [Срок оценки: 6, 12 months post-PDT treatment]
(Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine [Срок оценки: 7 days post-PDT treatment]
Differences in post-PDT redness with PDT + imipramine [Срок оценки: 10 min, 30 min, 24 hours post-PDT treatments]
Differences in post-PDT pain with PDT + imipramine [Срок оценки: 10 min, 30 min, 24 hours post-PDT treatments]

Критерии участия

Критерии включения

Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
Subjects must have a VA physician's order to receive PDT treatment on their forearms.
Willing to participate and understand the informed consent document.
Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
Has stable transportation to attend study visits at DVA