National Register of Moderate and Severe Adult Atopic Dermatitis (ATOPYREG)

June 9, 2025 updated by: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Collect clinical history and treatment data of AD in adulthood;

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The nature of the study is descriptive. Each centre undertakes to recruit all adult patients diagnosed with moderate-severe atopic dermatitis observed at the center.

Description

Inclusion Criteria:

  1. Age 18 years
  2. Signature of informed consent

  3. 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:

      1. location in at least one of the following "critical" locations: face, hands, genitals
      2. QID > 10
      3. VAS itching > 7
      4. VAS sleep > 7

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological data
Time Frame: from baseline through study completion, an average of 3 year
Reassessment of the epidemiology of AD
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
Assessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD
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
Assessment of any comorbidities;
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
Outlining possible diagnostic criteria specific to AD in adults;
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
Evaluation of the natural history of AD and identification of possible conditioning factors;
from baseline through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Piergiacomo MD Calzavara Pinton, Asst Spedali Civili Di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SID01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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