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Recruiting

NCT Number: NCT06313333

National Register of Moderate and Severe Adult Atopic Dermatitis

Collect clinical history and treatment data of AD in adulthood;

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location status: Recruiting

Location contact

Piergiacomo MD Calzavara Pinton

CONTACT

[email protected]

0303995305

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Epidemiological data

    Time frame: from baseline through study completion, an average of 3 year

    Reassessment of the epidemiology of AD

  2. Identification of factors for specific treatment

    Time frame: 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

  3. clinical and therapeutic data

    Time frame: from baseline through study completion, an average of 3 year

    Assessment of any comorbidities;

  4. characterization of diagnostic criteria

    Time frame: from baseline through study completion, an average of 3 year

    Outlining possible diagnostic criteria specific to AD in adults;

  5. Assessment of possible conditioning factors

    Time frame: from baseline through study completion, an average of 3 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Piergiacomo MD Calzavara Pinton

CONTACT

[email protected]

0303995305

Sponsors and collaborators

Lead sponsor

Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Other

Registry information

Official study title

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Acronym: ATOPYREG

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Mar 15, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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