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RecruitingNCT06313333ATOPYREGUpdated Jun 12, 2025

National Register of Moderate and Severe Adult Atopic Dermatitis

An observational study in Atopic Dermatitis, sponsored by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

Collect clinical history and treatment data of AD in adulthood;

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Epidemiological data

    Reassessment of the epidemiology of AD

    Time frame: from baseline through study completion, an average of 3 year

  2. 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

    Time frame: from baseline through study completion, an average of 3 year

  3. clinical and therapeutic data

    Assessment of any comorbidities;

    Time frame: from baseline through study completion, an average of 3 year

  4. characterization of diagnostic criteria

    Outlining possible diagnostic criteria specific to AD in adults;

    Time frame: from baseline through study completion, an average of 3 year

  5. Assessment of possible conditioning factors

    Evaluation of the natural history of AD and identification of possible conditioning factors;

    Time frame: from baseline through study completion, an average of 3 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06313333
Lead sponsor
Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Responsible party
Sponsor
First posted
Mar 15, 2024
Start date
Jun 15, 2020
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jun 12, 2025

Study contacts

Piergiacomo MD Calzavara Pinton
Contact
piergiacomo.calzavarapinton@unibs.it
0303995305
Piergiacomo MD Calzavara Pinton
principal investigator · ASST Spedali Civili di Brescia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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