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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

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 4 months later.
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

  • Atopic Dermatitis

Browse trials for

03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years
  2. Signature of
  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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Dec 2030, 126 months after the start.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 126 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2023
First posted
Mar 15, 2024
StartActual
Jun 15, 2020
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Jun 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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