National Register of Moderate and Severe Adult Atopic Dermatitis

NCT ID: NCT06313333

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2030-12-31

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piergiacomo MD Calzavara Pinton

Role: PRINCIPAL_INVESTIGATOR

ASST Spedali Civili di Brescia

Locations

ASST Spedali Civili di Brescia

Brescia, Brescia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Piergiacomo MD Calzavara Pinton

Role: CONTACT

piergiacomo.calzavarapinton@unibs.it

0303995305

Facility Contacts

Piergiacomo MD Calzavara Pinton

Role: primary

piergiacomo.calzavarapinton@unibs.it

0303995305

Other Identifiers

SID01

Identifier Type: -

Identifier Source: org_study_id