Меню
Идёт набор NCT06244212

Topical Treatment for Atopic Dermatitis

Без фазы С лечением Atopic Dermatitis

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: Demonstration of applying triamcinolone cream, Mobile App Use, Standard of Care.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis. Базовые параметры: от 9 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 →

Обзор

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.

Подробное описание

Unlike most modes of medication administration, topical medications do not have a standardized method of dosage administration\] Although qualitative administration measures exist, these measures are often arbitrary and not quantifiable (i.e., "a fingertip"). In such cases, inappropriate dosing (i.e., using too much or too little) is an essential cause of treatment failure, and measurements of adherence for topical medications should consider the amount of medication administered. In a study analyzing the response to treatment in psoriatic patients, patients who received a standardized dose of topical calcipotriol achieved a more significant decrease in mean Psoriasis Area and Severity Index (PASI) (47%) compared to patients who were not standardized (17%, P\<0.0001). Moreover, over two-thirds of psoriatic patients deemed initially poor responders in the standardized regimen group were considered responsive to treatment after further consideration.

Given topical options' low cost, efficacy, and excellent safety profiles, they are the first line treatment option for mild-to-moderate Atopic Dermatitis (AD) treatment. This study will aim to assess differences in the amount of medication dispensed in two groups of patients with atopic dermatitis. The first will undergo a brief educational demonstration by a trained professional to highlight the appropriate amount of topical medication to dispense for their disease involvement. The second group will be a control group and receive the same medication; however, the Participants will receive standard of care education (verbal and written instructions) only. Data from the two groups will be collected and analyzed to measure trends in dosing (i.e., if the correct dosage quantity and frequency was dispensed).

Вмешательства

  • Другое Demonstration of applying triamcinolone cream
    Live demonstration of applying 1 fingertip unit of triamcinolone cream
  • Поведенческое Mobile App Use
    Additional mobile application that provides amount dispensed and adherence data.
  • Другое Standard of Care
    Written/verbal instructions only

Первичные конечные точки

  • Amount of Topical Medication Dispensed - Demonstration Group [Срок оценки: Day 7]
  • Amount of Topical Medication Dispensed - Standard of Care Group [Срок оценки: Day 7]
  • Amount of Topical Medication Dispensed - Mobile Application Group [Срок оценки: Day 7]
  • Number of times of Application - Demonstration Group [Срок оценки: Day 7]
  • Number of times of Application - Standard of Care Group [Срок оценки: Day 7]
  • Number of times of Application - Mobile Application Group [Срок оценки: Day 7]
  • Change in Investigator Global Assessment (IGA) Scores [Срок оценки: Baseline and Day 7]
  • Change in Percentage of Body Surface Area (BSA) affected [Срок оценки: Baseline and Day 7]
  • Subject Questionnaire Scores [Срок оценки: Day 7]

Критерии участия

Критерии включения

  • Diagnosis of skin dermatitis
  • Age > 9
  • Ability to return for a one-week clinical studies follow-up
  • Patients who are candidates for treatment with 0.1% triamcinolone ointment (even if they weren't in the study)
  • Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.

Критерии исключения

  • Patients without the diagnosis of skin dermatitis
  • Inability to return for a one week follow up appointment
  • Body Surface Area (BSA) affected <2%

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT06244212 · IRB00108458

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗