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临床试验/NCT06313333
NCT06313333招募中不适用

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Epidemiological data

研究概览

简要总结

Collect clinical history and treatment data of AD in adulthood;

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 but with at least one of the following conditions:
  • location in at least one of the following "critical" locations: face, hands, genitals
  • VAS itching > 7
  • VAS sleep > 7

排除标准

  • 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.

结局指标

主要结局

Epidemiological data

时间窗: from baseline through study completion, an average of 3 year

Reassessment of the epidemiology of AD

Identification of factors for specific treatment

时间窗: from baseline through study completion, an average of 3 year

Assessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD

clinical and therapeutic data

时间窗: from baseline through study completion, an average of 3 year

Assessment of any comorbidities;

characterization of diagnostic criteria

时间窗: from baseline through study completion, an average of 3 year

Outlining possible diagnostic criteria specific to AD in adults;

Assessment of possible conditioning factors

时间窗: from baseline through study completion, an average of 3 year

Evaluation of the natural history of AD and identification of possible conditioning factors;

次要结局

未报告次要终点

研究者

发起方
Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
申办方类型
Other
责任方
Sponsor

研究点 (1)

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