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National Register of Moderate and Severe Adult Atopic Dermatitis

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06313333
Acronym
ATOPYREG
Enrollment
1500
Registered
2024-03-15
Start date
2020-06-15
Completion date
2030-12-31
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Epidemiological datafrom baseline through study completion, an average of 3 yearReassessment of the epidemiology of AD
Identification of factors for specific treatmentfrom baseline through study completion, an average of 3 yearAssessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD
clinical and therapeutic datafrom baseline through study completion, an average of 3 yearAssessment of any comorbidities;
characterization of diagnostic criteriafrom baseline through study completion, an average of 3 yearOutlining possible diagnostic criteria specific to AD in adults;
Assessment of possible conditioning factorsfrom baseline through study completion, an average of 3 yearEvaluation of the natural history of AD and identification of possible conditioning factors;

Countries

Italy

Contacts

Primary ContactPiergiacomo MD Calzavara Pinton
piergiacomo.calzavarapinton@unibs.it0303995305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026