Clinical trial NCT06313333: National Register of Moderate and Severe Adult Atopic Dermatitis
Official title: Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Epidemiological data
timeFrame: from baseline through study completion, an average of 3 year
measure: Identification of factors for specific treatment
timeFrame: from baseline through study completion, an average of 3 year
measure: clinical and therapeutic data
timeFrame: from baseline through study completion, an average of 3 year
measure: characterization of diagnostic criteria
timeFrame: from baseline through study completion, an average of 3 year
measure: Assessment of possible conditioning factors
timeFrame: from baseline through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Piergiacomo MD Calzavara Pinton
role: PRINCIPAL_INVESTIGATOR
References: