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Идёт набор NCT06313333

National Register of Moderate and Severe Adult Atopic Dermatitis

Наблюдательное 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis. 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Обзор

Collect clinical history and treatment data of AD in adulthood;

Подробное описание

Atopic dermatitis is a chronic-recurrent inflammatory skin disease with high prevalence in children and frequently presenting clinical remission during or after childhood; however, it may persist and/or recur, even after long and transient remission, adulthood. In addition, in some adult patients, DA is not present in pediatric age, but onset in adulthood: the investigators speak, in these cases, of adult-onset DA. The prevalence of DA is increasing all over the world and the cases in which clinical manifestations appear or persist during adolescence and/or adulthood are increased especially in industrialized countries. are not currently available specific laboratory markers for diagnosis of DA and, therefore, diagnosis is eminently clinical. In fact, at the present time, there are no validated diagnostic criteria, nor is there a clear consensus on diagnostic-therapeutic pathway to be followed when evaluating patients with adult DA. For these reasons, the collection of data related to various aspects of the DA such as those epidemiological, medical and clinical history, as well as the impact of the disease on the quality of life, results of crucial importance for estimating the real prevalence of this disease in Italy and also, possibly, to outline possible diagnostic criteria specific to adult DA, so that to facilitate and improve the diagnostic-therapeutic path of the patient. The intention of the project, therefore, is to create and use a National Register dedicated to DA patients in adulthood regardless of the period of onset of their pathology. aim to place the Italian Register as a supranational reference for international studies conducted on the adult DA.

Первичные конечные точки

  • Epidemiological data [Срок оценки: from baseline through study completion, an average of 3 year]
  • Identification of factors for specific treatment [Срок оценки: from baseline through study completion, an average of 3 year]
  • clinical and therapeutic data [Срок оценки: from baseline through study completion, an average of 3 year]
  • characterization of diagnostic criteria [Срок оценки: from baseline through study completion, an average of 3 year]
  • Assessment of possible conditioning factors [Срок оценки: from baseline through study completion, an average of 3 year]

Критерии участия

Критерии включения

  • Age 18 years
  • Signature of informed consent
  • Diagnosis of moderate and/or severe DA by a dermatologist specialist defined on the basis of following criteria (10):
  • EASI 16
  • EASI <16 but with at least one of the following conditions:
  • location in at least one of the following "critical" locations: face, hands, genitals
  • QID > 10
  • VAS itching > 7
  • VAS sleep > 7

Критерии исключения

  • Patient unable to provide informed consent prior to any collection procedures data on the study;
  • unable to complete the procedures required for the study;
  • a patient already participating in another follow-up register of the same disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • ASST Spedali Civili di Brescia — Brescia

Идентификаторы

NCT: NCT06313333 · SID01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗