National Register of Moderate and Severe Adult Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto
Overview
Collect clinical history and treatment data of AD in adulthood;
Detailed description
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.
Primary outcome measures
- Epidemiological data [Time frame: from baseline through study completion, an average of 3 year]
- Identification of factors for specific treatment [Time frame: from baseline through study completion, an average of 3 year]
- clinical and therapeutic data [Time frame: from baseline through study completion, an average of 3 year]
- characterization of diagnostic criteria [Time frame: from baseline through study completion, an average of 3 year]
- Assessment of possible conditioning factors [Time frame: from baseline through study completion, an average of 3 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- ASST Spedali Civili di Brescia — Brescia
Identifiers
NCT: NCT06313333 · SID01