National Register of Moderate and Severe Adult Atopic Dermatitis

NCT06313333 | Recruiting

• 1 other identifier: SID01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Collect clinical history and treatment data of AD in adulthood;

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Epidemiological data

  Reassessment of the epidemiology of AD

  from baseline through study completion, an average of 3 year

• 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

• clinical and therapeutic data

  Assessment of any comorbidities;

  from baseline through study completion, an average of 3 year

• characterization of diagnostic criteria

  Outlining possible diagnostic criteria specific to AD in adults;

  from baseline through study completion, an average of 3 year

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 years
• Signature of informed consent
• 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:
• location in at least one of the following "critical" locations: face, hands, genitals
• QID \> 10
• VAS itching \> 7
• VAS sleep \> 7

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Piergiacomo MD Calzavara Pinton

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piergiacomo MD Calzavara Pinton

CONTACT

0303995305; piergiacomo.calzavarapinton@unibs.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: March 15, 2024
• Study Start: June 15, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

IT (1)