Меню
Идёт набор NCT07056569

Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters

Без фазы С лечением Dermatitis, Contact Dermatitis Dermatitis, Chronic Dermatitis, Eczematous

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: 047_TD Dermatitis cream twice a day for 28 days.
Кому может быть актуально
Состояния в реестре: Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous. Базовые параметры: 6 мес. — 65 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
Италия
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 →

Обзор

The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.

Подробное описание

The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors.

The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.

Вмешательства

  • Устройство 047_TD Dermatitis cream twice a day for 28 days
    047\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.

Первичные конечные точки

  • Performance measured by reduction of disease severity and symptoms [Срок оценки: End of treatment - 28 days.]
Вторичные конечные точки (10)
  • Performance measured by reduction of disease severity and symptoms at 14 days [Срок оценки: 14 days of treatment]
  • Eczema improvement assessed by Eczema Area and Severity Index (EASI) score [Срок оценки: Treatment day 14 and treatment day 28]
  • Pruritus improvement assessed by VAS [Срок оценки: Treatment day 14 and treatment day 28]
  • Anti-itch effect measured by patient reported assessment [Срок оценки: Day 1 of treatment]
  • Long lasting itch relief measured by patient reported assessment [Срок оценки: Treatment day 14 and 28]
  • Performance measured by improvement in the Quality of Life [Срок оценки: Treatment day 1, 14 and 28]
  • Subject adherence to treatment [Срок оценки: From enrollment to the end of study on day 28]
  • Product usability [Срок оценки: From enrollment to the end of study on day 28]
  • Overall performance of the device [Срок оценки: From enrollment to the end of study on day 28]
  • MD Safety evaluation [Срок оценки: From enrollment to the end of study on day 28]

Критерии участия

Критерии включения

  • Male/ female > 6 months < 65 years
  • Patient diagnosed AD/CD
  • Patient with EASI max <16
  • Patient with IGA 1-3
  • Patient in good condition with no serious systemic disease

Критерии исключения

  • Hypersensitivity to any 047\_TD Dermatitis cream ingredients
  • Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
  • Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
  • Any use of another topical emollient or other established treatment for AD/CD during the study at the site of flares (AD/CD lesions). Exception are usual hygienic products in the diaper area
  • A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
  • Drug abuser
  • Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old
  • Could not provide written informed consent or parents' informed consent to have their child participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Италия · 3 центра
  • Studio Medico Pigatto Bersani — Milan
  • Poliambulatorio Verona — Verona
  • Studio Medico — Voghera

Идентификаторы

NCT: NCT07056569 · 047 TD - BK2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗