National Register of Moderate and Severe Adult Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ATOPYREG  

Official title:

Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313333
• Other study ID #: SID01
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: June 15, 2030

Study information

• Verified date: March 2024
• Source: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
• Contact: Piergiacomo MD Calzavara Pinton
• Phone: 0303995305
• Email: piergiacomo.calzavarapinton[@]unibs.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Collect clinical history and treatment data of AD in adulthood;

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 15, 2030
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Italy	ASST Spedali Civili di Brescia	Brescia

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological data	Reassessment of the epidemiology of AD	from baseline through study completion, an average of 3 year
Primary	Identification of factors for specific treatment	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
Primary	clinical and therapeutic data	Assessment of any comorbidities;	from baseline through study completion, an average of 3 year
Primary	characterization of diagnostic criteria	Outlining possible diagnostic criteria specific to AD in adults;	from baseline through study completion, an average of 3 year
Primary	Assessment of possible conditioning factors	Evaluation of the natural history of AD and identification of possible conditioning factors;	from baseline through study completion, an average of 3 year